Cohort of Patients With Pelvic Gynecological Cancer: Constitution of a Collection of Biological Samples With Radioclinical Characterization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: collection of sample and data.
- Who it may be relevant to
- Registry conditions: Pelvic Neoplasms, Endometriosis. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other collection of sample and data
Recovery of surgical waste during surgery planned in the current care and clinical data collection
Primary outcome measures
- circulating tumor and DNA [Time frame: 2 years]
- Endometriosis tumor and DNA [Time frame: 2 years]
Secondary outcome measures (9)
- circulating tumor DNA [Time frame: 5 years]
- circulating tumor DNA [Time frame: 10 years]
- circulating Micro RNA [Time frame: 2 years]
- circulating Micro RNA [Time frame: 5 years]
- circulating Micro RNA [Time frame: 10 years]
- circulating cytokines [Time frame: 2 years]
- circulating cytokines [Time frame: 5 years]
- circulating cytokines [Time frame: 10 years]
- Tumoral DNA [Time frame: day of surgery]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 2 centers
- CHI Creteil — Créteil
- CHU Tenon — Paris
Identifiers
NCT: NCT03622983 · PELVIMASS2 · 2016-A00613-48