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Tumor Microenvironment in Ovarian Cancer

NCT06272240RecruitingOBSERVATIONAL

Summary

A detailed understanding of molecular mechanism of cancer genesis is fundamental to develop innovative and personalized therapies. The new frontier in biomedical research is represented by organoids, a three-dimensional cell culture system obtained from a tissue fragment that accurately reproduces the essential properties of the original tissue in vitro, which could provide a valuable model for explanation of ovarian cancers pathogenesis and will allow to predict the response to a specific therapy. With this research project, we expect to generate ovarian cancer organoids to characterize in vitro interactions and molecular pathway among tumor cells, immune cells, and resident microbiota (intratumoral bacteria and/or microbial-derived molecules).

Key Facts

Lead Sponsor

University of Udine

Enrollment

Start Date

2024-01-02

Completion Date

2024-07-01

Study Type

OBSERVATIONAL

Official Title

Study of the Role of the Tumor Microenvironment in Ovarian Cancer

Interventions

Ovarian Cancer Organoids

Conditions

Ovarian Cancer Stage IIIOvarian Cancer Stage IV

Eligibility

Age Range

18 Years – 80 Years

Sex

FEMALE

Inclusion Criteria:

* Age \> 18 years
* Age \< 80 years
* Serous ovarian carcinoma
* FIGO Stage III-IV

Exclusion Criteria:

* Ongoing or suspended immunosuppressive therapy within the last 6 months
* Congenital or acquired immunodeficiency
* Immunosuppressive state
* Administration of chemotherapy for another neoplasm in the past 12 months
* Non-epithelial ovarian tumors
* Patients not undergoing surgical intervention
* BMI \> 30
* Absence of Informed Consent

Outcome Measures

Primary Outcomes

• Composition of the tumor microenvironment (including the immune system and intratumoral microbiota). • Generate organoids

Characterize the composition of the tumor microenvironment (including the immune system and intratumoral microbiota). Generate organoids from cells derived from ovarian tissue.

Time frame: from enrollment to the end of follow up at 36 months

Locations

Università degli Studi di Udine, Udine, Italy

Linked Papers

Study of the Role of the Tumor Microenvironment in Ovarian Cancer ( MICO ): A Prospective Monocentric Trial

ABSTRACT Background Ovarian cancer (OC) is one of the most aggressive tumors requiring new therapeutic approaches. Immunotherapy represents an opportunity, but to date, OC patients do not appear to benefit from current protocols. A better understanding of the composition of the tumor microenvironment (TME), especially in its immune components, could unveil mechanisms of immune suppression in a useful way to predict response to therapies and develop new therapeutic approaches. Method The MICO (tumor MICroenvironment of Ovarian cancer) study is a single‐center observational study. Starting from peritoneal biopsy of high‐grade serous ovarian carcinoma (HGSOC), the purpose of the MICO study is to generate tumor patient‐derived organoid (PDOs) cultures and evaluate the concordance between in vitro platinum‐based chemotherapy sensitivity and in vivo sensitivity. Simultaneously, we will characterize through multiparameter cytofluorimetric analysis the composition of the OC TME, focusing on B lymphocytes and mast cells whose roles in ovarian cancer remain controversial and underinvestigated. Furthermore, patients experiencing recurrence will be longitudinally followed to monitor changes in the TME composition and the responsiveness of PDOs to in vitro stimulation with drugs. Discussion The association between the composition of the TME, the reactivity of the PDOs, and patients' disease progression will be analyzed to identify whether specific subpopulations of tumor‐infiltrating immune cells could be predictive factors of the disease outcomes. The comparison of molecular profiles, in vitro response to drugs, and clinical‐pathological data will allow the definition of a pattern capable of predicting the response of the primary tumor for the identification of those patients who may benefit from specific treatment. Strengths and Limitations The results of our study could help to better understand the OC behavior, may have implications for the development of effective immunotherapy and targeted pharmacological therapies for epithelial OC in a personalized medicine perspective. This will be a monocentric trial with an involvement of only 43 patients, so further studies will need to confirm our results. Trial Registration The clinical trial has been registered at Clinical‐Trials.gov with the identifier NCT06272240 on 02/14/2024

Linked Investigators

Alessandro Mangogna

Eleonora Capezzali

Giuseppe Vizzielli

- December 2021 - at present: Associate Professor in Gynecology and Obstetrics, Department of Medicine, University of Udine, University Hospital of Udine, Italy. - April 2021 – November 2021: Medical Doctor at Clinic of Obstetrics and Gynecology - "Santa Maria della Misericordia" University Hospital, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy - April 2015 - April 2021: Medical Doctor at “Fondazione Policlinico Universitario“Agostino Gemelli”, IRCCS, Catholic University of the Sacred Heart, Rome, Italy. - January 2014 - November 2014: Medical Doctor at “Fondazione di Ricerca e Cura "Giovanni Paolo II", Catholic University of the Sacred Heart, Campobasso, Italy. Member of the Italian Society of Gynaecological Endoscopy (SEGI) affiliated with the European Society of Gynecologic Endoscopy (ESGE). A national representative for gynecologists of the Italian Polyspecialist Society of Young Surgeons (SPIGC) and the Italian Society of Gynecology and Obstetrics (SIGO-YOUNG). Author of more than 150 peer-reviewed papers (www.pubmed.com) with an H-Index of 33 (by Scopus) and with more than 2000 citations (by Scopus). Principal Investigator and Co-Investigator of many phase I/II/III clinical trials in gynecologic oncology. Principal Investigator of the National research project, Call 2019. Project code: GR-2019-12371435. Project Title: Longitudinal genomic and transcriptomic analysis on ovarian cancer organoids. Project ID: TAILOR (Protocol number: 11959/20, Protocol ID: 3046). ClinicalTrials.gov Identifier: NCT04555473. Faculty of national and international standardized training programs for advanced laparoscopic and/or robotic gynecological surgery. Expert in gynecologic oncology, especially in studying advanced ovarian cancer, endometrial and cervical carcinoma. More recently, he has dedicated himself to studying radical pelvic surgery and pharmacological tests on gynecologic tumors by ex-vivo tissues. Official reviewer of many indexed international journals as well as Lancet Oncology, European Journal of Surgical Oncology, World Journal of Surgical Oncology, European Journal of Obstetrics and Gynecology and Reproductive Biology, Archives of Gynecology and Obstetrics, Case Reports in Obstetrics and Gynecology, Chinese Journal of Cancer Research, BMC Cancer. Associated Editor of Frontiers in Oncology (Women’s cancer and Gynecologic Oncology subsection), BMC Cancer, and World Journal of Surgical Oncology.

Martina Arcieri