Endometrial Neoplasms

Cervical Cytology DNA Methylation for Endometrial Lesion Screening and Follow-up

The goal of this observational study is to evaluate the accuracy of a novel molecular test for screening and monitoring endometrial lesions in women at medium-to-high risk for endometrial cancer. The main questions it aims to answer are: * What is the sensitivity and specificity of the CISENDO test (a DNA methylation test on cervical cytology samples) for detecting histologically confirmed endometrial intraepithelial neoplasia (EIN) or invasive endometrial cancer? * How do DNA methylation levels change during the follow-up of endometrial lesions? Researchers will compare the results of the CISENDO test to the results from the standard diagnostic procedure (hysteroscopy with histology) to see if the molecular test can reliably identify high-risk lesions and track disease progression. Participants will: * Provide a residual liquid-based cervical cytology sample for the CISENDO test. * Undergo a standard diagnostic hysteroscopy examination (with or without biopsy) for comparison. * Some participants will return for follow-up visits at 6 and 12 months for repeat methylation testing and/or hysteroscopy to monitor their condition.

The Role of POLE Mutation in High Risk Endometrial Cancer.

The actual role of POLE mutations in high-risk endometrial cancer is undetermined. The main question it aims to answer is: What is the prevalence of POLE mutations in high-risk endometrial cancer case? What is the impact of POLE mutations in real world high-risk endometrial cancer case?

A Study of LY4257496 in Participants With Cancer (OMNIRAY)

The main purpose of this study is to evaluate safety, tolerability, and efficacy of LY4257496 alone and as part of relevant standard of care (SOC) combination therapy in participants with Gastrin-releasing Peptide Receptor (GRPR)-positive advanced breast, colorectal, prostate, and endometrial cancer. The study will also evaluate the safety, tolerability, and efficacy of LY4257529 to identify cancer with high levels of a protein called GRPR. This is a 2-part study. Participation could last up to 36 weeks or until your tumor progresses.

A Study of LY4175408 in Participants With Advanced Cancer

The purpose of this study is to measure the safety and efficacy of LY4175408 in participants with selected advanced cancer. In addition, this study will evaluate how much LY4175408 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it. Participation could last up to 4 years.

Comparison of Two-Position and Four-Position Cervical Injection Techniques for Sentinel Lymph Node Mapping in Endometrial Cancer Using Methylene Blue

This clinical trial evaluates lymph node mapping in newly diagnosed endometrial cancer patients undergoing surgery. The standard technique uses a 2-point methylene blue cervical injection. The study aims to determine if increasing injection points improves mapping success.

Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors

The objective of this study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BL-M17D1 in patients with HER2-Expressing or HER2-Mutant Advanced or Metastatic Solid Tumors.

A Study of DM002 in Patients With Advanced Solid Tumors

The goal of study： The study has two parts: Part 1 Dose Escalation and Part 2 Dose Expansion. In Part 1, a few participants will receive the lowest dose of study drug. The study team will make sure it is safe and tolerated before enrolling new participants at a higher dose of study drug. There will be up to six or more dose levels of study drug tested (called cohorts). Which dose you receive will depend on how many participants have taken part in the study before you. The purpose of Part 1 of the study is to evaluate the safety of the study drug at different dose levels, to understand what your body does to the study drug, and to find the best dose of study drug in people who have advanced solid tumor cancers. In Part 2, participants will receive the best dose level that was determined in Part 1 of the study. The purpose of Part 2 of the study is to evaluate the safety of the study drug at the dose level determined in Part 1, to understand what your body does to the study drug, and to see how your cancer responds to the study drug. Participants will: Participants will have 17 or more visits to the study centre. This study has a screening phase of up to 28 days , and a treatment phase with cycles of 21 days each. Participants will also have an End of Treatment (EOT) visit 21 days after the final study drug treatment, and a Follow-up visit 30 days after the EOT visit . Participants will be contacted by telephone every 3 months after the Follow-up visit to check on the wellbeing and record any new anticancer therapy they may have started.

A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors

The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity to determine the preliminary recommended dose for expansion (RDE) of NKT3964 in adults with advanced or metastatic solid tumors. The goal of the Expansion phase of the study is to evaluate the preliminary anti-tumor activity of NKT3964 at the RDE based on objective response rate (ORR) and determine the preliminary recommended Phase 2 dose (RP2D).

First-line Carboplatin and Paclitaxel in Combination With Pembrolizumab, Followed by Maintenance Pembrolizumab With or Without Nesuparib, in Patients With Newly Diagnosed Advanced or Recurrent MMR-proficient (pMMR) Endometrial Cancer

The goal of this study is listed below. Part A (Safety Run-in Phase) : To determine feasibility of pembrolizumab and nesuparib combination as maintenance therapy in patients with MMR-proficient advanced and recurrent endometrial cancer. Feasibility is defined as a dose-limiting toxicity (DLT) rate less than or equal to 33%. Part B (Randomization Phase) : To evaluate the efficacy of pembrolizumab and nesuparib combination/ pembrolizumab monotherapy as maintenance therapy in patients with MMR-proficient advanced stage and recurrent endometrial cancer. Efficacy will be assessed by investigator assessed progression free survival (PFS) as assessed by RECIST 1.1.

Translational Study of MSS, TP53 Mutation and Chromosome Instability Relationship in Endometrial Carcinoma

The objective is to understand the relationship between TP53 mutation, MSS and chromosome instability in endometrial cancer and the effect on clinical prognosis.We will collect a small amount of tumor tissue samples. NGS panel detection and WGD/AS analysis were performed on the tissue. Paracancer tissue was used as a negative control and relevant information in medical records during the operation. Then we will collect clinical diagnosis and disease information through telephone follow-up after the completion of the operation.

Cadonilimab With Chemoradiation for Recurrent and Oligometastatic Endometrial Carcinoma

The goal of this clinical trial is to evaluate the efficacy and safety of cadonilimab in combination with paclitaxel, cisplatin, and radiation therapy for the treatment of locally recurrent and oligometastatic endometrial carcinoma. The main questions it aims to answer are: 1. Does the combination therapy improve the overall response rate (ORR), progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and safety in participants? 2. What are the predictive biomarkers of treatment efficacy, and how can this information better guide the use of immune-oncology drugs in combination therapy? Participants will: * Receive cadonilimab, paclitaxel, cisplatin, and radiation therapy according to a specified protocol. * Visit the clinic for regular checkups and tests throughout the treatment period. * Be monitored for and have records kept of ORR, PFS, DCR, OS, and safety. * Provide hematologic and tissue samples to explore biomarkers. This study will help determine if this combination therapy can become a new standard of care for patients with locally recurrent and oligometastatic endometrial carcinoma, as well as identify biomarkers to better guide treatment strategies.

Tislelizumab in Combination With Chemotherapy as a Neoadjuvant Treatment for Advanced Endometrial Cancer

The goal of this clinical trial is to evaluate the efficacy and safety of tislelizumab in combination with chemotherapy as a neoadjuvant treatment for advanced endometrial cancer.

A Study of LY4170156 in Participants With Selected Advanced Solid Tumors

The purpose of this study is to find out whether the study drug, LY4170156, is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.

A Study With NKT3447 for Adults With Advanced/Metastatic Solid Tumors

The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) to determine the maximum tolerated dose (MTD) and/or preliminary recommended dose for expansion (RDE) of NKT3447 in adults with advanced or metastatic solid tumors. The goal of the Expansion phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and the preliminary antitumor activity of NKT3447 in adult subjects with cyclin E1 (CCNE1) amplified ovarian cancer at the RDEs selected in Dose Escalation and to determine the preliminary recommended phase 2 dose (RP2D).

Effect of Stress Ball Use on Anxiety Level During Endometrial Biopsy Procedure

The aim of this study is to determine the effect of stress ball application on the anxiety level during the endometrial biopsy procedure. This research is planned as a randomised controlled study. Place and time of the research: The research is planned with patients who will undergo endometrial biopsy procedure in Zonguldak Obstetrics and Gynecology Hospital affiliated to the Ministry of Health. While there are various experimental studies in the literature on the effect of stress ball on anxiety during many painful procedures, there is no study in the literature on the effect of stress ball on anxiety level during endometrial biopsy procedure (Akarsu, Kuş \& Akarsu 2021, Genç 2021Nurdina, Anggraini \& Novyanda 2022, Srivarsan, Sridevi \& Preetha 2021, Yanks et al. 2018,) In this study, it was aimed to evaluate the effect of stress ball application on anxiety level during endometrial biopsy procedure

A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7/ ENGOT-ov80 Study)

Multicenter, randomized, open-label, phase II clinical study comparing Dostarlimab +/- Bevacizumab with standard chemotherapy in patients with gynecological clear cell carcinoma. 198 subjects will be enrolled in this study and will be assigned to three groups in a 1:1:1 ratio. 1. Group A: Dostarlimab monotherapy * First 3 cycles: Dostalimab 500mg every 3 weeks, IV * 4 cycles \~ up to 24 months: Dostalimab 1000mg every 6 weeks, IV 2. Group B: Dostarlimab + Bevacizumab combination therapy * First 3 cycles: Dostalimab 500mg every 3 weeks, IV * 4 cycles \~ up to 24 months: Dostalimab 1000mg every 6 weeks, IV * Bevacizumab administered IV at 15 mg/kg every 3 weeks until disease progression or unacceptable toxicity 3. Group C: General chemotherapy (one of Pegylated liposomal doxorubicin, Doxorubicin, Paclitaxel, and Gemcitabine)

MRI Radiomics Combined With Pathomics on the Prediction of Molecular Classification and Prognosis of Endometrial Cancer

Molecular typing provides accurate information for the diagnosis, treatment and prognosis prediction of endometrial cancer, which has important clinical significance. However, due to its high cost and complicated process, it is difficult to be widely used in clinical practice. Based on the artificial intelligence method, this study fused the characteristics of MRI radiomics and pathomics, combined with the clinical pathological information, built a model to predict the molecular typing and prognosis, analyzed the biological characteristics of endometrial cancer from the multi-scale level, guided the personalized and precise diagnosis and treatment, in order to improve the prognosis of patients.

A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2

This clinical trial is studying advanced or metastatic solid tumors. Once a solid tumor has grown very large in one spot or has spread to other places in the body, it is called advanced or metastatic cancer. Participants in this study must have head and neck cancer, non-small cell lung cancer, endometrial cancer, or ovarian cancer. In the first part of the study, participants must have tumors that have a marker called HER2. This clinical trial uses an experimental drug called disitamab vedotin (DV). DV is a type of antibody-drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. In this study, all participants will get DV once every 2 weeks. This study is being done to see if DV works to treat different types of solid tumors that express HER2. It will also test how safe the drug is for participants. This trial will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the disease.

Study of Induction PD-1 Blockade (Nivolumab) in Patients With Surgically Complete Resectable Mismatch Repair Deficient Endometrial Cancer (NIVEC)

phase 2 clinical trial to confirm the pathological complete response rate of PD-1 blocker use in patients with Mismatch Repair Deficiency(MMRd) endometrial cancer that can be completely resected surgically.

DETERMINE Trial Treatment Arm 02: Atezolizumab in Adult, Paediatric and Teenage/Young Adult Patients With Cancers With High Tumour Mutational Burden (TMB) or Microsatellite Instability-high (MSI-high) or Proven Constitutional Mismatch Repair Deficiency (CMMRD) Disposition

This clinical trial is looking at a drug called atezolizumab. Atezolizumab is approved as standard of care treatment for adult patients with urothelial cancer, non-small cell lung cancer, extensive-stage small cell lung cancer, hepatocellular carcinoma and triple negative breast cancer. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Atezolizumab works in patients with these types of cancers which have certain changes in the cancer cells called high tumour mutational burden (TMB) or high microsatellite instability (MSI) or proven (previously diagnosed) constitutional mismatch repair deficiency (CMMRD). Investigators now wish to find out if it will be useful in treating patients with other cancer types which are also TMB/MSH-high or show CMMRD. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future. This trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.

POLE-END REAL LIFE: Endometrial Cancer Early Stages I-II and Advanced Stages III and IV Evaluation of POLE as a Prognostic Factor. Participants Are Women >= 18 Years Old, With the Pole Mutation

POLE-END is a non-profit, observational, retrospective and prospective study which aims to analyze the clinical course of patients with POLE-mutated endometrial cancer with evaluation of Recurrence-Free Survival (RFS), defined as the interval of time between the diagnosis of POLE-mutated endometrial carcinoma and the diagnosis of disease recurrence (radiological and/or clinical and/or histological diagnosis). In particular, the investigator want to study the influence of the POLE mutation on the survival of patients and therefore on the appearance of relapses by collecting only clinical and anatomopathological-molecular data. The study also has the secondary objective of correlating the clinical outcome with known prognostic factors and with the treatments administered. The data will be collected on a specific Data Collection Form, made anonymous and sent to the promoting center for final analysis. The study will be conducted according to the attached protocol, in compliance with the rules of Good Clinical Practice. The treatment of patients will take place according to normal clinical practice and there are no additional costs borne by the Company and the Regional Health Service. Patient enrollment will take place within the centers belonging to the MITO group that have signed up. Patients will be followed in their respective centers for the duration of their treatments and up to the fifth year after the initial diagnosis of endometrial cancer. The number of patients enrolled for this study will be approximately 80 and will have a maximum overall duration of 9 years. As a non-profit studio, we request exemption from paying research evaluation costs.

Robotic-assisted Versus Conventional Laparoscopic Surgery in Obese Patients With Early Endometrial Cancer

Data across literature suggest that robotic surgery may offer benefit specifically in patient with morbid obesity with endometrial cancer, but to date no randomized trials have been conducted to confirm these observations. This randomized controlled multicentric trial aims to evaluate the most appropriate minimally invasive surgical approach in morbidly obese (BMI \>= 30) patients with endometrial carcinoma.

Early Intervention to Prevent Lower Limb Lymphedema of Gynecological Malignancy

This study is a prospective, randomized, controlled clinical trial of a single center in China and plans to enroll 400 patients. 1. Patients with diagnosed gynecological malignancies who underwent pelvic and abdominal lymphadenectomy and required pelvic radiotherapy; 2. Random grouping (A:B=3:1): A. Prophylactic lymphoedema treatment; B. Standard care group; 3. Preventive lymphedema health education was given to patients with gynecological malignant tumors without contraindications before surgery. All patients were randomly divided into an intervention group and a nonintervention group. The intervention group received preventive lymphedema treatment twice a week. 10 times, and the interval between the two treatments was not less than 48 hours and not more than 2 weeks. The intervention measures included four parts: manual lymphatic drainage, skin care, functional exercise, and wearing lymphedema preventive compression stockings. In the nonintervention group, knowledge education and telephone follow-up were routinely conducted. 4. All patients were evaluated for edema, lymphedema symptoms and quality of life 1 day before radiotherapy, every Friday during radiotherapy and every 3 months thereafter. Bioelectrical impedance measurement and leg diameter measurement were used to evaluate edema, the Gynecologic Cancer Lymphedema Questionnaire (GCLQ) was used to evaluate lymphedema symptoms, and the EORTC Quality of Life Scale (QLQ-C30) was used to evaluate quality of life. followed up to 2 years after the end of lymphedema prophylaxis.

Uterine Manipulator Versus No Uterine Manipulator in Endometrial Cancer Trial

Minimally invasive surgery is the recommended approach in endometrial cancer (EC) patients based on the results of two randomized controlled trials, given its advantages without compromised oncologic outcomes. The uterine manipulator is commonly used in benign and malignant pathologies to perform a laparoscopic or robotic hysterectomy. However, although regularly used, the uterine manipulator adoption in EC is a controversial technical aspect due to the raised concerns regarding the possible risk of disruption of the tumor mass, the spread of malignant cells, and seeding of the disease, particularly at the level of the vaginal cuff or spread of tumor cells, with increased risk of recurrence and death due to EC. On that basis, given that hysterectomy without a uterine manipulator is feasible, only a randomized controlled trial comparing oncologic outcomes in EC patients after use versus not use of the uterine manipulator will be able to provide high-quality evidence to answer this critical question and allow or exclude the use of a uterine manipulator during minimally invasive hysterectomy for EC.

Inflammatory Index as a Predictor for Endometrial Cancer: an Observational Study

It is a prospective observational trial. Primary goal is identification of an association between alteration of systemic inflammation indices, such as neutrophil-to-lymphocyte ratio (NLR), platelet-t- lymphocyte ratio (PLR), lymphocyte-to-monocyte ratio (MRL) and patients risk classification according to European Guidelines. The population is represented by all women being admitted to the Gynecology Ward, through Emergency, who are affected by endometrial cancer. Participants will undergo surgery, and freely express their consent to participate in the study.

An Observational Study Based on Endometrial Cancer Risk Screening Model

The goal of this observational study is to test the efficiency of our endometrial cancer risk screening calculator, and improve the endometrial cancer risk screening model to form a stable and reliable non-invasive auxiliary diagnostic tool with high sensitivity and specificity in healthy women.The main question it aims to answer is: ·the efficiency of our endometrial cancer risk screening calculator Participants will be collected demographic information, as well as ultrasound, blood routine test and other test results, which will be entered into the endometrial cancer risk screening calculator to obtain high-risk or low-risk prediction results.

The Impact of Epigenetic MMRd in Endometrial carcinomas-a Real World Study

In recent years, the incidence of endometrial carcinoma (EC) has increased significantly and patients tends to be younger. In addition to known risk factors such as obesity, hypertension and diabetes, genetic factors also play an important role in the occurrence and development of EC. Among them, Mismatch Repair Defect (MMR) can produce mutant phenotypes, leading to cancer susceptibility. Although some articles indicated that epigenetic MMRd, one type of MMRd, predicted poor prognosis among endometrial carcinoma patients, hitherto, the clinicopathological significance and prognosis of epigenetic MMRd has not been determined. To date, there are no relevant large-sample data to investigate the prevalence of epigenetic MMRd in Chinese population, as well as the impact on the prognosis of endometrial cancer. In this setting, The purpose of this study was to investigate the prevalence of epigenetic MMRd and its impact on clinicopathology and prognosis on endometrial cancer among Chinese patients.

Online Adaptive Radiotherapy for Postoperative Treatment of Endometrial and Cervical Cancer

Online adaptive radiotherapy (oART) has demonstrated to be feasible to reduce planning target volume (PTV) margins for postoperative treatment of endometrial and cervical cancer. To explore the value of reduced margins in oART for postoperative treatment of endometrial and cervical cancer, we conducted a prospective clinical trial to determine the clinical efficacy and toxicity of reduced margins.

Optimal Margin Evaluation of Online Adaptive Radiotherapy for Postoperative Treatment of Endometrial and Cervical Cancer

Online adaptive radiotherapy has demonstrated to be feasible to reduce inter-fractional radiotherapy errors as it re-optimizes treatment plan every fraction. To investigate the extent and value of margin reduction，we conduct a prospective clinical trial to determine the optimal margin and toxicity of smaller margin.

GnRHa + Letrozole in Non-obese Progestin-insensitive Endometrial Cancer and Atypical Hyperplasia Patients

To investigate the efficacy of GnRHa plus letrozole vs Diane-35 plus metformin in non-obese progestin-insensitive early-stage endometrial cancer (EEC) and atypical hyperplasia(EAH) patients asking for conservative treatment.

GnRHa + Letrozole in Obese Progestin-insensitive Endometrial Cancer Patients

To investigate the efficacy of GnRHa plus letrozole in obese progestin-insensitive EEC patients.

A Study of SGN-ALPV in Advanced Solid Tumors

This study will test the safety of a drug called SGN-ALPV in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). This study will have three parts. Parts A and B of the study will find out how much SGN-ALPV should be given to participants. Part C will use the dose and schedule found in Parts A and B to find out how safe SGN-ALPV is and if it works to treat solid tumor cancers.

Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15)

The purpose of this study is to assess the safety and efficacy of treatment with pembrolizumab (MK-3475) compared to a combination of carboplatin and paclitaxel in women with mismatch repair deficient (dMMR) advanced or recurrent endometrial carcinoma who have not previously been treated with prior systemic chemotherapy. The primary study hypotheses are that pembrolizumab is superior to the combination of carboplatin and paclitaxel with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and Overall Survival (OS).

A Study of Felmetatug Vedotin/SGN-B7H4V in Advanced Solid Tumors

The purpose of the study is to test the safety of the medicine called Felmetatug Vedotin alone and with pembrolizumab in participants with solid tumors. It will also look at the side effects of this medicine. A side effect is anything a medicine does to the body besides treating the disease. This study is seeking for participants who either have cancer: * that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable), * has spread through the body (metastatic), or have some cancer left over after surgery. This study will have five parts. * Parts A and B of the study will find out how much Felmetatug Vedotin should be given to participants. * Part C will use the amount found in Parts A and B to find out how safe Felmetatug Vedotin is and if it works to treat solid tumor cancers. * Part D will find out if and how much Felmetatug Vedotin can be given with pembrolizumab. * Part E will use the amount found in Part D to find out how safe Felmetatug Vedotin with pembrolizumab is and if it works to treat triple negative breast cancer.

Registry Platform Ovarian and Endometrial Cancer

The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with advanced or metastatic ovarian cancer (OC) or advanced or metastatic endometrial cancer (EC) in Germany.

A Study of PF-07260437 in Advanced or Metastatic Solid Tumors

A study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of PF-07260437, a B7-H4 x CD3 bispecific mAb, in participants aged ≥18 years of age with advanced or metastatic breast cancer, ovarian cancer or endometrial cancer. Adult participants with other advanced or metastatic high B7-H4 expressing tumors may be considered after discussion with and approval from sponsor.

Endometrial Lesions Predictions

To explore the risk factors of endometrial lesions in patients with abnormal uterine bleeding and establish prediction models which can discriminate between different endometrial etiologies of abnormal uterine bleeding(AUB).

MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)

The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer therapies in participants with selected advanced solid tumors. The primary hypothesis is that pembrolizumab/vibostolimab co-formulation is superior to pembrolizumab alone in terms of objective response rate or progression-free survival in participants with cervical cancer.

A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRα)

This study, ELU- FRα-1, was focused on adult subjects who have advanced, recurrent or refractory folate receptor alpha (FRα) overexpressing tumors considered to be topoisomerase 1 inhibitor-sensitive based on scientific literature, and, in the opinion of the Investigator, have no other meaningful life-prolonging therapy options available.

Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)

The purpose of this study is to find out whether the study drug, LY3537982, is safe and effective in cancer patients who have a specific genetic mutation (KRAS G12C). Patients must have already received or were not able to tolerate the standard of care, except for specific groups who have not had cancer treatment. The study will last up to approximately 4 years.

Real-time Lymphatic Channel Visualization Improves Bilateral Sentinel Lymph Node Detection in Endometrial Cancer

Endometrial cancer is the most common malignancy of the female genital tract. Standard treatment for early-stage disease includes hysterectomy, bilateral salpingo-oophorectomy, and lymph node assessment. Sentinel lymph node (SLN) mapping with indocyanine green (ICG) has become widely used as an alternative to systematic lymphadenectomy due to lower morbidity and high detection rates. This randomized clinical trial was designed to compare conventional cervical ICG injection with a modified technique, in which injection is continued until real-time lymphatic channels are visualized intraoperatively, for bilateral SLN detection in patients with clinical early-stage endometrial cancer undergoing robotic surgery.

Effect of Pelvic Radiotherapy on the Intestinal Microbiome and Metabolome

Eight in ten patients will develop bowel problems during radiotherapy, eg diarrhoea, pain and incontinence, half will develop difficult long-term bowel problems. It is not known why some people get bowel problems and others do not and there is no test to predict who will develop bowel problems following their treatment. There is a link between the changes in the number and type of gut bacteria (the microbiome) in some bowel conditions and it is possible to test for these different bacteria in a simple stool sample using genetic testing. Also gut bacteria produce different gases in the stool called "volatile organic compounds" (VOCs), which can be measured in stool samples. Specific VOC patterns have been seen in other bowel conditions and small studies suggesting that there are specific VOC and gut bacteria patterns in the stool of those undergoing pelvic radiotherapy which may help to identify people who will get difficult bowel problems. Diet can change the microbiome/VOCs so diet change could improve bowel symptoms after radiotherapy. The investigators would like to test stool samples of patients with womb, cervix or bladder cancer having pelvic radiotherapy to see if there are differences in the number/type of gut bacteria and VOCs between those who get severe bowel symptoms compared to those with mild bowel symptoms. They also want to see whether these differences in VOCs or gut bacteria can tell who will develop severe bowel symptoms during or after radiotherapy and determine the effect of diet. The first step is to run the study on a small scale to confirm that a larger study would work. This will make sure the investigators can recruit and consent people safely and will test the best ways of measuring bowels symptoms using several questionnaire options. They will collect the information needed to work out how many people would be needed in a large trial to fully test the theory. Ultimately, the investigators would like to use differences in the number/type of gut bacteria and VOCs to find ways to better prevent and treat bowel problems after pelvic radiotherapy.

[SENTRY] Tailoring Postoperative Management Through Sentinel Lymph Node Biopsy in Low- and Intermediate-Risk Endometrial Cancer

While total hysterectomy without lymph node staging is standard for low- and intermediate-risk endometrial cancer, certain histopathologic factors can necessitate additional interventions. Our study assesses the influence of sentinel lymph node (SLN) biopsy on postoperative decision-making.

HE4 in the Diagnostic Approach of Endometrial Cancer in Patients With Postmenopausal Bleeding

This study aims to explore the sensitivity of an innovative marker, HE4, in the diagnosis approach of endometrial cancer in case of postmenopausal bleedings.

A Study of Lenvatinib in Combination With Pembrolizumab in Korean Patients

The purpose of this study is to collect and evaluate the following information in relation to the safety and the efficacy of Lenvatinib in lenvatinib/pembrolizumab combination therapy in the post marketing setting: (1) Serious adverse events and serious adverse drug reactions (2) Unexpected adverse events and adverse drug reactions not reflected in the approved product package insert of lenvatinib in lenvatinib/pembrolizumab combination therapy (3) Known adverse drug reactions (4) Non-serious adverse drug reactions (5) Other safety and efficacy related information.

Study of AK112 in the Treatment of Advanced Gynecological Tumors

A phase II study to evaluate the efficacy and safety of AK112 in subjects with advanced gynecological tumors.

Time Restricted Eating (TRE) Among Native Hawaiian/Pacific Islander Women at Risk for Endometrial Cancer

The long-term goal of this study is to determine the efficacy of time restricted eating (TRE) for improving metabolic health and preventing endometrial cancer. The primary objective of the protocol is to conduct a 14-week two-arm randomized crossover trial of a dietary intervention to evaluate the feasibility, fidelity and preliminary acceptability of a TRE intervention among Native Hawaiian/Pacific Islander women at risk for developing endometrial cancer, and to provide proof of principle that TRE can improve metabolic health in this population.

A Study of SGN-STNV in Advanced Solid Tumors

This trial will look at a drug called SGN-STNV to find out whether it is safe for patients with solid tumors. It will study SGN-STNV to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study how well SGN-STNV works to treat solid tumors. The study will have two parts. Part A of the study will find out how much SGN-STNV should be given to patients. Part B will use the dose found in Part A to find out how safe SGN-STNV is and if it works to treat certain types of solid tumors.

Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053)

The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS.

Assessing Effectiveness and Implementation of an EHR Tool to Assess Heart Health Among Survivors

The objective of this hybrid effectiveness-implementation study is to examine the effects of an EHR-based cardiovascular health assessment tool (AH-HA) among breast, prostate, colorectal, endometrial, and Hodgkin and non-Hodgkin lymphoma cancer survivors (N=600) receiving survivorship care in community oncology practices, using a group-randomized trial design (6 intervention practices and 6 usual care practices). Our central hypothesis is that the AH-HA tool will increase (1) cardiovascular health (CVH) discussions among survivors and oncology providers, (2) referrals and visits to primary care and cardiology (care coordination), and (3) cardiovascular (CV) risk reduction and health promotion activities compared to usual care.

COM701 in Combination With BMS-986207 and Nivolumab in Subjects With Advanced Solid Tumors.

This is a phase 1/2 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary antitumor activity of COM701 in combination with BMS-986207 and nivolumab in patients with advanced solid tumors.

Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer

A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.

The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Endometrial and Cervical Cancer. A Multicenter Study.

The role of small-volume lymph node disease (ITC and micro metastases) among patients with endometrial or cervical cancer submitted to sentinel node (SLN) procedure is not clearly defined. This study was designed to create a dataset of patients with lymph nodal disease. Data on type and volume of lymph nodal disease, therapeutic choices and oncological outcomes (DFS, OS, recurrence rate) will be collected and analyzed. This will allow to define the groups of patients who may need or for whom it can be avoided any adjuvant treatment on the basis of lymph node status.

Endometrial Malignancy in Breast Cancer Patients With or Without AUB

In order to assess the hysteroscopic, histopathologic, and ultrasonographic aspects of uterine monitoring in postmenopausal breast cancer patients with or without abnormal uterine bleeding (AUB), as well as to calculate the risk of endometrial cancer in women with or without AUB.

Characterization of the Genetic Profile of Type 2 Endometrial Carcinoma in Martinique

In Martinique, about 33 new cases are diagnosed per year, with a high incidence rate of type 2 endometrial carcinoma which has a poor prognosis with few therapeutic options. Although targeted therapies are used in many types of cancer, they are still possible a minority of patients. In current practice, endometrial cancers do not benefit these therapies. Characterization of the molecular mechanisms involved in the genesis of type 2 endometrial carcinoma could help to identify biomarkers predictive of a response to targeted therapies. We propose to identify the genetic profile of type 2 endometrial carcinomas in Martinique.

Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001) - China Extension Study

The purpose of this study is to compare the efficacy of pembrolizumab + lenvatinib to chemotherapy in female participants with Stage III, IV, or recurrent endometrial carcinoma. It is hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR). It is also hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for overall survival (OS). As of Amendment 7 eligible participants on study completion will be able to transition to an extension study, if available, in which they can continue to receive pembrolizumab monotherapy, lenvatinib monotherapy, or a combination of both pembrolizumab and lenvatinib as received in the parent study.

A Study of E7386 in Combination With Other Anticancer Drug(s) in Participants With Solid Tumor

The primary objective of this study is to assess the safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of E7386 in combination with other anticancer drug(s), and to determine the optimal dose of E7386 in combination with lenvatinib in endometrial carcinoma (EC) (for EC Dose Optimization Part only).

Durvalumab and Olaparib in Metastatic or Recurrent Endometrial Cancer

The DOMEC trial is designed as a Dutch Gynecological Oncology Group (DGOG), prospective, multi-center, phase II study for 55 patients with advanced (recurrent, refractory or metastatic) endometrial cancer or carcinosarcoma of the uterus to investigate the efficacy of the combination therapy of olaparib tablets and durvalumab IV.

Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001)

The purpose of this study is to compare the efficacy of pembrolizumab + lenvatinib to chemotherapy in female participants with Stage III, IV, or recurrent endometrial carcinoma. It is hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR). It is also hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for overall survival (OS). As of Amendment 7 eligible participants on study completion will be able to transition to an extension study, if available, in which they can continue to receive pembrolizumab monotherapy, lenvatinib monotherapy, or a combination of both pembrolizumab and lenvatinib as received in the parent study.

Sentinel Lymph Node Mapping In Endometrial Cancer

Lymph node assessment provides the crucial information about the prognosis of endometrial cancer. Sentinel lymph node stands in the first station on the lymph node metastasis pathways. While traditional systemically lymph node resection would bring a lot of complications, sentinel node mapping and biopsy is a feasible way with less damage to evaluate whether lymph node metastasis occurs in endometrial cancer patients, due to less lymph nodes resected. However, the process of this technology in endometrial cancer isn't well established. The investigators intend to conduct a prospective and multicentric study to evaluate the effectiveness of different mapping methods to achieve a reliable lymph node assessment. Endometrial cancer patients in each center will be recruited in the investigators' study with inclusion and exclusion criteria. After the patients signing the informed consent form, the surgery process will be performed, including sentinel lymph node mapping with Carbon Nanoparticles (CNP) or CNP combining Indocyanine Green(ICG), hysterectomy with or without bilateral adnexectomy, pelvic and para-aortic lymph node resection, sequentially. All resected nodes will be pathologically exanimated. Then the data obtained will be analyzed and discussed deeply and finally lead to a conclusion.

Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775])

This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) versus treatment of physician's choice (doxorubicin or paclitaxel) for the treatment of advanced endometrial cancer. Participants will be randomly assigned to receive either pembrolizumab and lenvatinib or treatment of physician's choice. The primary study hypothesis is that pembrolizumab in combination with lenvatinib prolongs progression free survival (PFS) and overall survival (OS) when compared to treatment of physician's choice.

Pembrolizumab in Combination With Doxorubicin in Advanced, Recurrent or Metastatic Endometrial Cancer

This is a non-randomized, single arm, multi-center, phase II study of pembrolizumab in combination with doxorubicin in subjects with recurrent/metastatic endometrial cancer.

Does Cediranib With Paclitaxel, or Cediranib and Olaparib, Treat Advanced Endometrial Cancer Better Than Paclitaxel?

The COPELIA trial is evaluating two new tablet medications in endometrial cancer for the first time. It will include 129 women aged 16 years or older with advanced endometrial cancer whose cancer has worsened after their initial chemotherapy treatment. Participants will be allocated at random to one of three groups: 1. The first group (Arm 1) will receive a standard (routine) treatment for patients with endometrial cancer known as paclitaxel. This is a chemotherapy drug that is routinely used to treat patients with different cancers including ovarian, breast, lung and endometrial cancer. Paclitaxel works by stopping the growth of cancer cells. 2. The second group (Arm 2) will receive the standard paclitaxel treatment once a week in addition to a new drug called cediranib. Cediranib is a tablet medication and works by blocking new blood vessel formation. Cediranib has been tested in women with endometrial cancer before but not alongside chemotherapy treatment. 3. The third group (Arm 3) will receive two new tablet medications, cediranib and olaparib. Olaparib works by preventing cancer cells repairing DNA effectively. The use of olaparib and cediranib together has been shown to be effective in a common type of ovarian cancer but has not been evaluated as a treatment for endometrial cancer before. The main objectives of the COPELIA trial are to work out: 1. Whether the two new treatments, cediranib-paclitaxel (Arm 2) and cediranib-olaparib (Arm 3) are more effective at controlling endometrial cancer than standard paclitaxel chemotherapy (Arm 1) 2. Whether the two new treatments cause more or fewer side-effects than standard chemotherapy 3. How each of these treatments impact on the daily life of women receiving the treatment by asking trial participants to regularly complete quality of life questionnaires 4. Whether we can learn how these treatments work in women with endometrial cancer by taking some additional blood tests for research.

Correlation Between Hysteroscopic Diagnosis of Endometrial Hyperplasia and Histopathological Examination

A prospective cohort study at a Tertiary University Hospital. From January to December 2018, we enrolled women with the following criteria: abnormal uterine bleeding in post-menopause, endometrial thickening in pre-or post-menopause; tamoxifen usage. Patients underwent office hysteroscopy with a 5-mm continuous-flow hysteroscope and endometrial biopsies were taken using miniaturized instruments. Senior operators had to foresee histopathological diagnosis using a questionnaire. Histopathological examination was conducted to confirm the diagnosis.

CureOne Registry: Advanced Malignancy or Myelodysplasia, Tested by Standard Sequencing and Treated by Physician Choice

Registry participants with advanced malignancy or myelodysplasia will have a sample of their tumor or tissue analysed for genetic alterations using next generation sequencing (NGS) performed in a lab that has been certified to meet a high quality standard. Treatments and outcomes will be reported to the registry to allow further understanding of how genetic differences can lead to better diagnosis and treatments.

Survival Outcomes of Uterine Malignancies in Chinese Population

This study aims to determine survival outcomes (overall survival and progression-free survival) of primary uterine malignancies in China and relevant risk factors in a prospective cohort study.

Study of Universal Screening for Lynch Syndrome in Chinese Patients of Endometrial Cancer

In patients diagnosed as endometrial cancer by thorough pathologic examinations, Lynch syndromes are screened by (1)immunohistochemical staining (for MLH1, MSH2, MSH6 and PMS2), (2) tests of microsatellite instability and (3) clinical criteria (Amsterdam I or II criteria and Bethesda criteria). For patients with any suspicious discoveries of Lynch syndromes from aforementioned screening methods, a molecular diagnosis with next-generation sequencing for mismatch repair genes (MLH1, MSH2, MSH6, PMS2, and EPCAM) is given to confirm Lynch syndromes. For patients of Lynch syndromes and endometrial cancer, relatives of blood lineage are tested by Sanger method or qPCR to find out carriers of mutation genes of Lynch syndromes.

Can Staging Magnetic Resonance Imaging (MRI) Features Prognosticate Patients Presenting With Endometrial Cancer?

Aim: Assess the value of MRI features in predicting prognosis in patients with endometrial cancer This study will examine the MRI features of women with confirmed endometrial cancer to see if textural features can prognosticate patients.

Can the iKnife Distinguish Between Normal and Malignant Endometrial Tissue?

Aim: Determine if Rapid Evaporative Ionization Mass Spectrometry (the iKnife); can diagnose cancer and pre-cancer from endometrial tissue biopsy samples. Women attending a gynaecology clinic for assessment of abnormal bleeding will receive an pelvic (internal) ultrasound as routine standard of care. If any abnormalities are detected, a tissue sample will be needed. If women are agreeable a second tissue sample will be taken for research. The first will be analysed by conventional means (histopathology). The second sample with new technology called the 'iKnife'. This is a modified type of Mass spectrometry device, that separates particles based on their mass charge ratio. The idea being that if tissue is burnt, gas is produced, and this gas contains lots of ions that can be analysed by the iKnife. Each type of tissue (cancer or non-cancer) will have a unique signature that the iKnife can use to distinguish between samples. If effective it could be used in future outpatient clinics to provide a one-stop, true point of care diagnosis.

Pilot Study: Can Ultrasound Guided Biopsy be Used as an Alternative to Hysteroscopy?

Aim: Assess accuracy of histological diagnosis using ultrasound guided biopsy for women with suspected endometrial cancer (as an alternative to hysteroscopy guided biopsy). All women presenting to clinic with suspected endometrial cancer will have an internal ultrasound. If the endometrial lining is thickened an endometrial biopsy will be performed. This can sometimes be done in an outpatient clinic, or sometimes a hysteroscopy and biopsy is needed (on a different day). Hysteroscopy guided biopsy has the advantage of enabling the clinician to perform directed biopsies under vision. Ultrasound guided biopsy is a ubiquitous procedure when used elsewhere in the body however it is not routinely used in this context. It does have the advantage of being easily performed on the same day as the first consultation. In this pilot study the diagnostic ability and tolerability of ultrasound guided biopsy of women with suspected cancer will be assessed as an alternative to hysteroscopy guided biopsy.

Can 3D Ultrasound be Used as an Alternative to MRI to Assess Myometrial Invasion in Endometrial Cancer?

Aim: Assess the diagnostic accuracy of 3D Ultrasound, compared to MRI and final histology with respect to myometrial invasion of endometrial cancer. This study will assess whether 3D ultrasound is accurate at predicting myometrial invasion aqnd lymph node metastasis of endometrial cancer. All patients will receive routine standard of care (MRI). The results of the 3D ultrasound will be compared to the MRI report and final histology.

Serum Biomarkers in Diagnosis and Predicting Prognosis of Ovarian Cancers

This study evaluates the usefulness of serum levels of trefoil factor 3 (TFF3), secreted frizzled related protein 4 (sFRP-4), reactive oxygen species modulator 1 (Romo1) and nuclear factor (NF)-κB as potential diagnostic and prognostic biomarkers in ovarian carcinoma.

Lenvatinib in Second Line Endometrial Carcinoma

The primary objective of this multicenter, randomized phase II trial is to assess the efficacy, as measured by progression-free survival (PFS), of lenvatinib compared to doxorubicin in advanced or recurrent endometrial cancer. The main secondary objective is to evaluate the predictive value of Ang-2 on lenvatinib activity and establishing a cutoff value as potential selection criteria for phase III. Other secondary objectives are to assess the tolerability and safety of lenvatinib in this setting and overall survival, response and disease control.

Fertility-sparing Therapy for Patients With Stage IA Endometrial Cancer

The goal of this clinical trial is to explore the feasibility and outcome of fertility-sparing therapy in Stage IA G1-G2 Endometrial Cancer with less than 1/2 myometrial invasion. Researchers will render participants indication-extended fertility-sparing therapy. Researchers will compare the myometrial invasion group with the no myometrial invasion group to see if it is possible to propose an extension indication of fertility-sparing therapy for endometrial cancer.

HORIZONS: Understanding the Impact of Cancer Diagnosis and Treatment on Everyday Life

The purpose of this study is to invite all people diagnosed with cancer who meet the eligibility criteria to complete questionnaires before their treatment begins and at regular intervals over time to assess the impact of cancer and its treatment on people's lives in the short, medium and long term. We will explore a range of factors to determine their role in both recovery of health and well-being and self-management. Although it is known that people who have had cancer are likely to experience a number of physical and psychological problems as a result of the disease and treatment, it is not known what the 'typical' course of recovery of health and well-being looks like, how long it takes and how this can be influenced. We will determine pathways to recovery of health and well-being following cancer diagnosis (initially breast cancer diagnosed \<50 years, Non-Hodgkin Lymphoma and gynaecological cancers) and identify what factors influence this. This includes assessing the relative importance of the person's illness, personal attributes, perceived burden of treatment, role of the environment they live in, including health / social care and personal networks of support, and their ability and capacity to self-manage. We will identify who is most at risk of problems and what environmental supports and resources people are able to mobilise to support their self-management. We will also explore who has the confidence and ability to manage during and beyond treatment and what factors influence this and whether this leads to earlier problem resolution and restoration of health and well-being. This knowledge will be used to develop and test future supportive interventions to enhance the rapid recovery of health and well-being - our long term aim being to design ways of helping people with cancer in areas we identify as problematic for them.

A Study of Sapanisertib, Combination of Sapanisertib With MLN1117, Paclitaxel and Combination of Sapanisertib With Paclitaxel in Women With Endometrial Cancer

The primary purpose of this study is to determine if sapanisertib in combination with weekly paclitaxel improves progression-free survival (PFS) compared to weekly paclitaxel alone.

Indocyanine Green Versus Blue Dye for Detection of Sentinel Lymph Node In Endometrial Cancer

To determine the difference in the proportion of hemipelves with successful detection of Sentinel Lymph Node according to the dye used (indocyanine green with near-infrared imaging vs blue dye) in women with endometrial cancer.

Ponatinib in the Treatment of FGFR Mutation Positive Recurrent or Persistent Endometrial Carcinoma

To test the patient's cancerous tumor to see if it has a FGFR mutation and, if so, to see how their cancer responds to a treatment with the drug ponatinib as well as examine the side effects caused by ponatinib.

Universal Screening for Lynch Syndrome in Women With Endometrial and Non-Serous Ovarian Cancer

This study will maximize identification of women with Lynch Syndrome using an enhanced screening strategy to identify those at risk. These women will be referred to genetic counselling for testing and those found to have Lynch Syndrome will be asked to invite first degree relatives to participate and undergo genetic testing for Lynch Syndrome. Screening guidelines and risk reducing surgery options for participants found to have Lynch Syndrome will be reinforced by the study and adherence to these guidelines will be assessed annually for ten years following Lynch Syndrome diagnosis to assess the impact and cost-effectiveness of this enhanced screening approach.

Diet and Physical Activity in Uterine Cancer Survivors

Endometrial cancer is the most common gynaecological cancer in developed countries with more than 75% of the patients surviving for at least five years. However, most endometrial cancer survivors are overweight and obese and do not meet the current nutrition and physical activity recommendations. This can lower their quality of life and increase their risk for chronic diseases. Behaviour change interventions can help them feel better about themselves and improve their quality of life. Applying them shortly after treatment seems ideal as cancer survivors feel motivated to make changes about their lifestyle at this time point. This study is to see if the investigators can design a project to measure how well a psycho-educational healthy eating and physical activity programme tailored to the survivors' needs works. Sixty-four endometrial cancer survivors diagnosed during the previous three years, and are all clear will be put by chance into one of two groups. One will receive the program. The other will receive usual care until the end of the trial and, then, a discussion and a self-help guide about eating well and being active following cancer treatment. This will help us to see if the programme makes a difference compared with usual care. The results will inform a larger study to test if a lifestyle program can improve the quality of life of uterine cancer survivors compared with usual care. The investigators will change the programme materials in response to the investigators' findings, making them available to services. The results will inform practice and research.

The Feasibility Study of the Li Brush for the Screening of Endometrial Cancer in the Postmenopausal Period

Investigators aim to collect endometrial sampling with Li Brush among target population who have risks for endometrial neoplasm, then Fractional curettage should performed with these participants, investigators intend to compare the pathological diagnosis results of cytology and fractional curettage to evaluate the sensitivity of Li Brush and investigators expect that the brush can be used for screening of endometrial cancer in the postmenopausal period in the clinic.

Cognitive-Existential Group Therapy to Reduce Fear of Cancer Recurrence: A RCT Study

Studies show that cancer survivors have unmet needs, the most frequently cited being fear of recurrence (FCR). Moderate to high levels of FCR have been reported by as much as 49% of cancer patients and are more prevalent among women. FCR is associated with psychological distress, lower quality of life, and increased health care utilization. Little evidence exists that these problems are being addressed by current medical management.

STELLA 2 Trial: Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Staging of Endometrial/Ovarian Cancer

The purpose of this study is to determine whether or not there are more complications in the extraperitoneal compared with the transperitoneal approach for laparoscopic aortic lymphadenectomy for the surgical staging of endometrial or ovarian cancer

Sentinel Lymph Node Detection in Endometrial Cancer

In endometrial cancer (EC) pelvic and paraaortic lymphadenectomy is performed only in high risk groups (with approximately 20% of patients having lymph node metastases (LNM)) whereas no lymphadenectomy is recommended in low risk groups despite 5% LNM. Moreover, preoperative risk group allocation is known to be erroneous in up to 15% of patients. A technique identifying sentinel lymph nodes (SLN) in endometrial cancer have the potential to spare extensive surgery in 80% of high risk patients, identify low risk patients with nodal metastases, diminish side effects caused by full lymphadenectomy and render some expensive preoperative risk group allocation measures unnecessary. A clinically useful SLN technique requires a high technical success rate, a clear definition of SLN, an algorithm taking into account that metastatic nodes not always accumulate tracer and a reproducible surgical algorithm. A definition of SLN requires knowledge on lymphatic anatomy. Unfortunately all tracers, dyes/radiotracers often result in an abundance of colored/ signaling nodes. Therefore, a definition of a SLN requires identification of efferent/afferent lymph vessels. Several publications describe sentinel node techniques in EC with a variety of tracers (various dyes, radiotracer, alone or in combination). Sentinel nodes are usually described as "radioactive nodes" or "colored nodes" only with no further discrimination. No study relate to an anatomical description of lymphatic pathways. The aims of this study is to systematically display the major anatomical pathways with the use of ICG and to evaluate a standardized and reproducible SLN surgical algorithm based on lymphatic anatomy and identification of efferent lymph vessels.

LUDEC Study - Pilot Study of the Lavage of the Uterine Cavity for the Diagnosis of Endometrial Carcinoma

The current pilot study aims at answering the scientific question, whether exfoliated cells from Endometrium Carcinoma (EC) can be detected in the lavage fluid from the uterine cavity and proximal fallopian tubes with the same sensitivity as in specimen from liquid-based cervical cytology. If this turns out to be the case, earlier detection, particularly of type II EC should be possible.

DOvEEgene/WISE Genomics: Diagnosing Ovarian and Endometrial Cancer Early Using Genomics

This study aims to develop and validate a test for detecting ovarian and endometrial cancers early. It relies on detecting somatic mutations that are associated with these cancers from a uterine pap test. A saliva sample is also collected that acts as an internal control and has the ability to detect deleterious germline mutations associated with common hereditary cancers (such as breast, ovarian, endometrial, colon, and pancreatic cancers). A machine learning classifier is then used to discriminate between cancer and benign disease.

Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology

To assess the adequacy of an endometrial biopsy sample obtained using sonohysterography.

Robotic Versus Abdominal Surgery for Endometrial Cancer

This study is intended to explore differences in oncologic and surgical safety between robotic assisted laparoscopy and conventional abdominal surgery for high risk endometrial cancer.

The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma

This randomized trial is studying the efficacy and safety of the hysterectomy alone compared with hysterectomy and bilateral salpingo-oophorectomy (BSO) for patients with Stage IA endometrial carcinoma.

The Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma

This randomized trial is studying the efficacy and safety of the chemotherapy compared with radiation therapy alone as adjuvant treatment after operation in Patients with high risk and Stage I endometrial carcinoma.

[F-18] Fluorothymidine PET/CT Imaging for Pelvic Cancers

\[F-18\] Fluorothymidine PET imaging will be used to create a radiation therapy treatment plan to avoid active bone marrow in the pelvis. This will be done to evaluate if sparing bone marrow will help maintain blood counts. This would impact chemotherapy administration.

STELLA Trial: Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Staging of Endometrial/Ovarian Cancer

The purpose of this study is to determine whether the extraperitoneal approach is better than the transperitoneal approach for laparoscopic aortic lymphadenectomy for the surgical staging of endometrial or ovarian cancer.

A Study Of Two Dual PI3K/mTOR Inhibitors, PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer

This study will investigate the individual safety and efficacy of two dual PI3K/mTOR inhibitors in patients with recurrent endometrial cancer.

Efficacy,Tolerability,Safety of Temsirolimus in Women With Platinum-refractory Ovarian Carcinoma or Advanced Endometrial Carcinoma

The purpose of this study is to determine the activity, tolerability and safety of Temsirolimus in women with ovarian cancer who progressed during the previous platinum chemotherapy alternatively within 6 months from completion of therapy or advanced endometrial carcinoma.

Early Detection of Cancers in Low Resource Countries

The purpose of this study is to implement a community-based combined program for early detection of breast, cervical, ovarian and endometrial cancer in low-resource countries delivered through a free standing or a mobile Well Woman Clinic. The goals of this program are to downstage cancers and improve mortality rates using low-cost early detection methods. These programs will be implemented in regions where early cancer detection strategies are not in place and cancers present at advanced stages with resultant high mortality. Currently, there are three target project sites: Cambodia (June 2011), India (June 2011), and Brazil (March 2011). Memorandums of Understanding have been secured with local health organizations in each region to establish clinic operations. Each clinic would serve an approximate target population of 100,000 amongst whom about 12,000 eligible women (4-5,000 annually) will be invited to be screened for breast and cervical cancer over a three-year time span.

Study of XL147 (SAR245408) in Advanced or Recurrent Endometrial Carcinoma

There has not been any systemic therapy approved in the United States or in Europe for treating advanced or recurrent endometrial cancer (EC). This study will evaluate the safety and preliminary efficacy of XL147 in advanced or recurrent EC. Constitutively active phosphatidylinositol-3 kinase (PI3K)/phosphatase and tensin homolog on chromosome 10 (PTEN) pathway signaling is common in EC and involved in the development and/or progression of the disease. PTEN deficiency and/or activating mutations/amplification in the PIK3CA gene that encodes the p110α catalytic subunit of PI3K have been frequently detected in EC patients. XL147 is a potent and highly selective inhibitor of the Class I PI3K family of lipid kinases. In addition, in vivo preclinical data have demonstrated that XL147 targets both proximal and distal signaling in the PI3K/PTEN pathway. Therefore, XL147 may have utility in the treatment of subjects with advanced or recurrent EC.

Sleep and Endometrial Cancer

This study proposes to test the hypothesis that zolpidem taken the night before major surgery for endometrial cancer will improve sleep efficiency and reduce post surgery pain, as well as reduce the need for analgesic medication.

Cost-Effectiveness and Patients Satisfaction of Conventional vs Robotic-Assisted Laparoscopy in Gynecologic Oncologic Indications

Laparoscopic surgery is gaining currency in the field of oncologic care, particularly for colorectal and gynecologic cancers. This innovation could be used either for staging purpose and therefore could steer global therapeutic options or for surgical management only. Increase knowledge and skills lead to an increase in the number and rate of the women this innovation could be offered. The project team observed a shift from traditional surgical management (abdominal radical surgery) towards laparoscopic with a focus on lymphadenectomy. This innovation however increases some costs (the surgical stage) but decrease some others (the post surgical stage). Foreseeing the pace of the dissemination needs to have objective and reliable data about who had access to laparoscopic surgery and who didn't (and why) and accurate assessment of related costs. This program will focus on uterine cancer (both cervix and corpus).

Sentinel Node and Endometrial Cancer

The purpose of this study is to investigate the relevance of sentinel node in endometrial cancer. Sentinel node is thought to reflect the status of lymph node. Only 10 to 20% of women with endometrial cancer exhibit lymph node metastasis hence systematic lymphadenectomy is questionable. In breast cancer, melanoma and vulvar cancer, sentinel node has emerged as an alternative to complete lymphadenectomy.

A Trial for Patients With Advanced/Recurrent Endometrial Cancer

The intent of this protocol is to screen a new agent for activity in patients with advanced or recurrent endometrial carcinoma. This phase II trial is studying how well pemetrexed disodium works in treating patients with advanced or recurrent endometrial carcinoma.

Tissue Bank of Biological Specimens From Patients With Gynecologic Disease

The purpose of this study is to create a tissue bank of gynecologic cancers and normal tissue for the study of cancer in order to better understand the changes occurring on a molecular level (DNA, RNA, protein) that lead to the development of cancer.

Diagnostic Imaging of Lymph Nodes in Gynaecologic Oncology

The purpose of the study is to determine the diagnostic accuracy of a new magnetic resonance imaging (MRI) technique, the diffusion weighted imaging with body background signal suppression (DWIBS) in the detection of lymph node pathology in patients with gynaecologic malignancies.

Questionnaire Study for Gynecological Cancer Survivors

The purpose of this study is to evaluate the quality of life of long-term gynecologic cancer survivors.

Mixture of Prebiotics on Intestinal Microbiota of Patients Receiving Abdominal Radiotherapy.

Abdominal and pelvic radiotherapy (RT) reduces the renewal capacity of the epithelium. Rectal biopsies obtained from patients receiving pelvic RT have revealed atrophy of surface epithelium, acute cryptitis, crypt abscesses, crypt distortion and atrophy, and stromal inflammation. Modifications in intestinal microbiota, such as an increase in the number of pathogens, may contribute to intestinal injury. The prebiotic effect of a carbohydrate is assessed by its capacity to stimulate the proliferation of healthy bacteria (Bifidobacterium, Lactobacillus) rather than pathogenic bacteria (Clostridium, E. coli). The hypothesis of the study is that a mixture of inulin and fructooligosaccharide could modulate Lactobacillus and Bifidobacterium and reduce the intestinal injury in patients affected of gynaecological cancer and treated with abdominal radiotherapy.

Phase 2 Study of ET-743 (Trabectedin) in Patients With Persistent or Recurrent Endometrial Carcinoma

The purpose of this is to test the safety and effectiveness of an investigational chemotherapy agent in patients with persistent or recurrent endometrial cancer.

Pre-Clinical Models in Gynecological Tumors A Tissue Repository

The purpose of this study is to provide a repository for long-term storage of endometrial cancer tumor and normal tissue, ascites and serum. This material will be used in studies to better understand the molecular biology of endometrial cancer.

Molecular Markers in Treatment in Endometrial Cancer

The purpose of this prospective multicenter trial is to investigate the value of molecular markers in endometrial cancer for predicting lymph node metastasis and prognosis in relation to treatment.

Studies of the Tumour Suppressor Gene PTEN - Endometrial Cancer

This project seeks to understand the role of the PTEN tumour suppressor gene in endometrial cancer (tumours of the uterine lining), the most common gynecologic cancer in the developed world. The studies in this program span the spectrum from fruit flies to humans, as part of a synergistic partnership that will significantly enhance our understanding of the molecular genetic events involved in the development and progression of endometrial cancer. The discovery of new targets for therapy, and the ability to evaluate these in subsequent clinical trials is a significant strength of this scientific interaction, which may result in cures for patients with primary and relapse endometrial cancer and prevention of this cancer in women who are at high risk.

Breast Cancer in Poland: An Expanded Study to Assess Occupational and Environmental Factors and Interactions With Genetics

The Polish breast, ovarian and endometrial cancer study is a complex molecular epidemiologic study that is expected to enroll about 2,500 breast cancer, 450 ovarian and 450 endometrial cancer cases and 2,500 controls from Warsaw and Lodz, two major cities in Poland. This large population-based study combines state-of-the-art techniques of exposure assessment and collection of biological specimens to allow for the study of a wide range of biomarkers. Exposure information is obtained through detailed personal interviews, anthropometric measurements, physical activity monitors, and collection of dust samples from the participants homes. The collection of biological specimens includes blood samples processed as cryopreserved whole blood, serum+ blood clot, plasma+buffy coat+red blood cells; 12-hour overnight urine; paraffin embedded tumor and normal tissue; and fresh tissue from tumors, non-neoplastic breast tissue and mammary fat tissue. Subject enrollment started in June 2000 and is expected to continue until January 2003 for breast cancer cases and controls and June 2003 for ovarian and endometrial cancer cases. As of May 2002, we have identified 2,207 breast, 138 ovarian and 235 endometrial cancer cases and 2,327 controls. The response rates to the interview are 81% for breast, 90% for ovarian and 83% for endometrial cancer cases and 70% for controls. Most women who agree to the interview agree to provide biological specimens (about 90% of cancer cases and controls agree to provide a blood sample), anthropometric measurements (95% of breast cancer cases and controls) and wear a physical activity monitor (79% breast cancer cases and 90% of controls)....

Colony-Stimulating Factor-1 (CSF-1) and Other Cytokines in Human Endometrial Carcinogenesis

The purposes of this study are the following: 1. To further characterize and quantify both CSF-1 and colony-stimulating factor-1 receptor (CSF-1R) expression from additional tumor specimens, specifically, tumors of high grade and from metastatic sites. 2. To assay using Enzyme-Linked ImmunoSorbent Assay (ELISA) sandwich monoclonal antibody methodology, CSF-1 expression in the peritoneal fluid and blood from patients with endometrial adenocarcinomas. 3. Using immunohistochemistry, to evaluate the presence of staining for CSF-1 and CSF-1R from additional patients with endometrial adenocarcinomas, especially of high grades and from metastatic sites. 4. To determine the extent of cytokine, specifically CSF-1, but also interleukin-1 (IL-1), IL-6, and granulocyte-macrophage colony-stimulating factor (GM-CSF), production, in endometrial carcinoma cells in primary cell culture. 5. To determine the responsiveness of epithelial cells on estrogen and antiestrogen binding, to determine if CSF-1 production is mediated, in these cells, by estrogen receptor binding, or alternative pathways of intracellular/cell-cell signal transduction. 6. The ultimate objective of these experiments is to characterize CSF-1 expression from benign and tumor cells in order to identify steps in the CSF-1 activated signalling pathways that may represent potential targets for therapy.

Chemotherapy With Whole Body Hyperthermia to Treat Resistant Breast, Endometrial, Cervical and Ovarian Cancers

Thermal therapy (hyperthermia of heat) can increase the effect of chemotherapy treatments. By itself, thermal therapy can also kill cancer cells. By using thermal therapy to treat the whole body, the investigators can treat cancer cells wherever they are throughout the entire body. In this study, the investigators are testing the combination of thermal therapy combined with chemotherapy to see: 1. if it improves the effect of the chemotherapy drugs, 2. if it helps the body fight the cancer cells, and 3. if this treatment is safe for the patient. This study does not offer heat treatment alone. Any patient with advanced or metastatic breast, or endometrial cancer resistant to standard treatment may be treated with the phase II protocol therapy; however, the patient will need to undergo some medical tests to make sure this treatment would be safe for them.

Multi-cancer Early Detection