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

NCT ID: NCT03622983

Last Updated: 2022-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2037-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pelvic Neoplasms Endometriosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Collection of sample and data

Collection of biological samples and clinical data

collection of sample and data

Intervention Type OTHER

Recovery of surgical waste during surgery planned in the current care and clinical data collection

Interventions

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collection of sample and data

Recovery of surgical waste during surgery planned in the current care and clinical data collection

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHI Creteil

Créteil, , France

Site Status RECRUITING

CHU Tenon

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Cyril Touboul

Role: CONTACT

Phone: 0156017000

Email: [email protected]

Facility Contacts

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Gregoire Miailhe, MD

Role: primary

Cyril Touboul

Role: primary

Other Identifiers

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2016-A00613-48

Identifier Type: OTHER

Identifier Source: secondary_id

PELVIMASS2

Identifier Type: -

Identifier Source: org_study_id