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Endometrial Cancer International Database

NCT04787159UNKNOWNOBSERVATIONAL

Summary

This project aims to determining prognostic factors and individualizing management decision per patient characteristics and endometrial cancer features. This study will include at least 10 centers from different countries that present at least Europe, South America, Asia, and Africa. Data will be retrospectively collected from January 2008 to December 2015 with a total follow-up of at least 5 years (December 2020).

Key Facts

Lead Sponsor

Assiut University

Enrollment

1000

Start Date

2021-05-01

Completion Date

2021-12-01

Study Type

OBSERVATIONAL

Official Title

Endometrial Cancer, a New Prospective Towards an Individually Adjusted Management Plans: A Multicenter International Study

Conditions

Endometrial Cancer

Eligibility

Age Range

18 Years – 75 Years

Sex

FEMALE

Inclusion Criteria:

* Women diagnosed with endometrial cancer, between 2008 and 2015.
* Women should be diagnosed and managed by the corresponding center.
* Patients with adequate clinical and pathological data.

Exclusion Criteria:

* Inadequate information and follow-up for at least 5 years.
* Authorization to use anonymous patient data for research purposes.

Outcome Measures

Primary Outcomes

Overall survival at 1 year

Number of women who are alive after cancer treatment divided by total number of patients at study onset

Time frame: At 1 year

Overall survival at 3 years

Number of women who are alive after cancer treatment divided by total number of patients at study onset

Time frame: At 3 years

Overall survival at 5 years

Number of women who are alive after cancer treatment divided by total number of patients at study onset

Time frame: At 5 years

disease free survival at 1 year

Number of women who are are disease free after cancer treatment divided by total number of patients at study onset

Time frame: At 1 year

disease free survival at 3 years

Number of women who are are disease free after cancer treatment divided by total number of patients at study onset

Time frame: At 3 years

disease free survival at 5 years

Number of women who are are disease free after cancer treatment divided by total number of patients at study onset

Time frame: At 5 years

Linked Papers

2021-01-13

Endometrial cancer: A society of gynecologic oncology evidence-based review and recommendations, part II

In 2014, the Society of Gynecologic Oncology's Clinical Practice Committee published a clinical update reviewing the treatment of women with endometrial cancer. At that time, there had been significant advances in the diagnosis, work-up, surgical management, and available treatment options allowing for more optimal care of affected women. This manuscript, Part II in a two-part series, includes specific recommendations on treatment of recurrent disease, post treatment surveillance and survivorship, considerations for younger women, and special situations. Part I covered histopathology and molecular pathology, risk factors, presentation and diagnostic approach, surgical approach and adjuvant therapy.

2020-05-28

Combined pelvic and para-aortic is superior to only pelvic lymphadenectomy in intermediate and high-risk endometrial cancer: a systematic review and meta-analysis

Lymph node metastasis is a principal prognostic factor for the treatment of endometrial cancer. Added value of para-aortic lymphadenectomy to only pelvic lymphadenectomy for intermediate/high-risk endometrial cancer patients remains controversial. A systematic review and meta-analysis was performed to assess the impact of combined pelvic and para-aortic lymph node dissection (PPALND) compared to only pelvic lymph node dissection (PLND) on survival outcomes of intermediate and/or high-risk patients. The systematic review and meta-analysis adhered to the PRISMA guidelines for meta-analyses of interventional studies. Pubmed, Scopus, EMBASE and Cochrane were searched up to April 20, 2018. Included studies were those comparing high-risk endometrial cancer patients that had performed pelvic and para-aortic lymph node dissection (PPALND) vs. only pelvic lymph node dissection (PLND) apart from standard procedure (total hysterectomy with bilateral salpingo-oophorectomy, TAHBSO). Primary outcomes of the study were overall survival and disease-free survival rates. Methodological quality of the included studies was assessed using the ROBINS-I tool. Overall quality of the evidence for the primary and secondary outcomes was evaluated as per GRADE guideline using the GRADE pro GD tool. There were 13 studies identified with 7349 patients included. All studies were retrospective observational as no RCTs or prospective studies adhering to inclusion criteria were retrieved. Combined pelvic and para-aortic lymphadenectomy was associated with 46% decreased risk for death (HR 0.54, 95% CI 0.35-0.83, I Combined pelvic and para-aortic lymphadenectomy is associated with improved survival outcomes compared with only pelvic lymphadenectomy in women with intermediate/high-risk endometrial cancers. Further prospective studies should be performed.

Linked Investigators

Stamatios Petousis