PELVIMASS2: Cohort of Patients With Pelvic Gynecological Cancer: Constitution of a Collection of Biological Samples With Radioclinical Characterization
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 Disease | Intervention/Treatment | Phase |
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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
Arms and Interventions
Arm | Intervention/Treatment |
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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
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Outcome Measures
Primary Outcome Measures
- circulating tumor and DNA [2 years]
- Endometriosis tumor and DNA [2 years]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of pelvic gynecological cancer posed on initial histological analysis or during recurrence;
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Or diagnosis of endometriosis on histology or imaging
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Age ≥ 18 years;
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Affiliation to the general social security scheme;
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Consent signed.
Exclusion Criteria:
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Refusal of the patient;
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Non-affiliation to the general social security scheme.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | CHI Creteil | Créteil | France | 94000 | |
2 | CHU Tenon | Paris | France | 75000 |
Sponsors and Collaborators
- Centre Hospitalier Intercommunal Creteil
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PELVIMASS2
- 2016-A00613-48