Cohort of Patients With Pelvic Gynecological Cancer: Constitution of a Collection of Biological Samples With Radioclinical Characterization (PELVIMASS2)

The management of pelvic gynecological cancers (PGC) is based on the determination of extension to guide treatments. The biology of the CGP is constantly evolving and personalized medicine adapted to this biology is currently in full development. For example, sequencing ovarian tumors can select patients who can benefit from anti-PARP therapy. There is therefore a need for patients to have biological samples of their tumor. Various studies on ovarian, endometrial and cervical cancer have sought to identify the factors predictive of recurrence of these cancers. The results obtained are very promising. This study will permit to collect biological samples and detailed clinical data that would allow to test hypotheses and develop a personalized medicine based on clinical and biological characteristics of patients.

Study Overview

• Status: Recruiting
• Conditions: Endometriosis; Pelvic Neoplasms
• Intervention / Treatment: Other: collection of sample and data

Detailed Description

The management of pelvic gynecological cancers (PGC) is based on the determination of the extension in order to guide the treatments. The biology of PGC is constantly evolving and personalized medicine adapted to this biology is currently in full development. For example, sequencing of ovarian tumors allows selection of patients who may benefit from anti-PARP therapy. There is therefore a need for patients to have biological samples of their tumor. Various studies on ovarian, endometrial and cervical cancer have sought to identify factors that predict recurrence of these cancers. The results have obtained are very promising, but if coordinator team have at our disposal fundamental and translational data related to the prognosis of PGCs, the coordinator team lack access to a biological collection of these cancers that would allow us to test our hypotheses and to develop personalized medicine related to the clinico-biological characteristics of the patients.

Endometriosis is the 1st cause of chronic pelvic pain (25-40% of women suffering during sexual intercourse) and represents the 1st cause of school and work absenteeism. Unfortunately, it is under-diagnosed and too often inappropriately managed. It is considered that 10 to 15% of the female population of reproductive age has endometriosis. This incidence reaches 50% in women with infertility. There are many similarities between deep endometriosis and pelvic cancers, whether on a physiopathological, epidemiological or clinical level. There are therefore many similarities in the surgical management as well as in the research strategies.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Cyril Touboul; Phone Number: +33 0156017000; Email: cyril.touboul@gmail.com

Study Locations

• France
  • Créteil, France, 94000
    • Recruiting
    • Chi Creteil
    • Contact: Gregoire Miailhe, MD; Email: Gregoire.Miailhe@chicreteil.fr
  • Paris, France, 75000
    • Recruiting
    • CHU Tenon
    • Contact: Cyril Touboul; Email: cyril.touboul@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

patients with pelvic gynecological cancer or with endometriosis

Description

Inclusion Criteria:

• Diagnosis of pelvic gynecological cancer posed on initial histological analysis or during recurrence;
• Or diagnosis of endometriosis on histology or imaging
• Age ≥ 18 years;
• Affiliation to the general social security scheme;
• Consent signed.

Exclusion Criteria:

• Refusal of the patient;
• Non-affiliation to the general social security scheme.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Collection of sample and data; Collection of biological samples and clinical data	Other: collection of sample and data; Recovery of surgical waste during surgery planned in the current care and clinical data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
circulating tumor and DNA	2 years
Endometriosis tumor and DNA	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
circulating tumor DNA	5 years
circulating tumor DNA	10 years
circulating Micro RNA	2 years
circulating Micro RNA	5 years
circulating Micro RNA	10 years
circulating cytokines	2 years
circulating cytokines	5 years
circulating cytokines	10 years
Tumoral DNA	day of surgery

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Anticipated): August 1, 2027
• Study Completion (Anticipated): August 1, 2037

Study Registration Dates

• First Submitted: August 1, 2018
• First Submitted That Met QC Criteria: August 6, 2018
• First Posted (Actual): August 9, 2018

Study Record Updates

• Last Update Posted (Actual): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endometriosis; Pelvic Neoplasms
• Other Study ID Numbers: PELVIMASS2; 2016-A00613-48 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No