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

Sponsor
Centre Hospitalier Intercommunal Creteil (Other)
Overall Status
Recruiting
CT.gov ID
NCT03622983
Collaborator
(none)
500
Enrollment
2
Locations
243
Anticipated Duration (Months)
250
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Cohort of Patients With Pelvic Gynecological Cancer: Constitution of a Collection of Biological Samples With Radioclinical Characterization
Actual Study Start Date :
May 1, 2017
Anticipated Primary Completion Date :
Aug 1, 2027
Anticipated Study Completion Date :
Aug 1, 2037

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. circulating tumor and DNA [2 years]

  2. Endometriosis tumor and DNA [2 years]

Secondary Outcome Measures

  1. circulating tumor DNA [5 years]

  2. circulating tumor DNA [10 years]

  3. circulating Micro RNA [2 years]

  4. circulating Micro RNA [5 years]

  5. circulating Micro RNA [10 years]

  6. circulating cytokines [2 years]

  7. circulating cytokines [5 years]

  8. circulating cytokines [10 years]

  9. Tumoral DNA [day of surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1CHI CreteilCréteilFrance94000
2CHU TenonParisFrance75000

Sponsors and Collaborators

  • Centre Hospitalier Intercommunal Creteil

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier:
NCT03622983
Other Study ID Numbers:
  • PELVIMASS2
  • 2016-A00613-48
First Posted:
Aug 9, 2018
Last Update Posted:
Jun 24, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 24, 2021