Clinical trial NCT03622983: Cohort of Patients With Pelvic Gynecological Cancer: Constitution of a Collection of Biological Samples With Radioclinical Characterization
Official title: Cohort of Patients With Pelvic Gynecological Cancer: Constitution of a Collection of Biological Samples With Radioclinical Characterization
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pelvic Neoplasms
Endometriosis
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with pelvic gynecological cancer or with endometriosis

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: circulating tumor and DNA
timeFrame: 2 years
measure: Endometriosis tumor and DNA
timeFrame: 2 years
Secondary outcomes:
measure: circulating tumor DNA
timeFrame: 5 years
measure: circulating tumor DNA
timeFrame: 10 years
measure: circulating Micro RNA
timeFrame: 2 years
measure: circulating Micro RNA
timeFrame: 5 years
measure: circulating Micro RNA
timeFrame: 10 years
measure: circulating cytokines
timeFrame: 2 years
measure: circulating cytokines
timeFrame: 5 years
measure: circulating cytokines
timeFrame: 10 years
measure: Tumoral DNA
timeFrame: day of surgery
Other outcomes:
Locations:
city: Créteil
country: France
facility: CHI Creteil
city: Paris
country: France
facility: CHU Tenon
Study officials:
References: