Cohort of Patients With Pelvic Gynecological Cancer: Constitution of a Collection of Biological Samples With Radioclinical Characterization
PELVIMASS2
2 other identifiers
observational
500
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2017
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2017
CompletedFirst Submitted
Initial submission to the registry
August 1, 2018
CompletedFirst Posted
Study publicly available on registry
August 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2037
December 21, 2022
December 1, 2022
10.3 years
August 1, 2018
December 20, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
circulating tumor and DNA
2 years
Endometriosis tumor and DNA
2 years
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Study Arms (1)
Collection of sample and data
Collection of biological samples and clinical data
Interventions
Recovery of surgical waste during surgery planned in the current care and clinical data collection
Eligibility Criteria
patients with pelvic gynecological cancer or with endometriosis
You may qualify if:
- 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.
You may not qualify if:
- Refusal of the patient;
- Non-affiliation to the general social security scheme.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHI Creteil
Créteil, 94000, France
CHU Tenon
Paris, 75000, France
Biospecimen
Biomarkers and tumoral samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2018
First Posted
August 9, 2018
Study Start
May 1, 2017
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2037
Last Updated
December 21, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share