Cohort of Patients With Pelvic Gynecological Cancer: Constitution of a Collection of Biological Samples With Radioclinical Characterization (PELVIMASS2)
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| ClinicalTrials.gov Identifier: NCT03622983 |
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Recruitment Status :
Recruiting
First Posted : August 9, 2018
Last Update Posted : June 24, 2021
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| Condition or disease | Intervention/treatment |
|---|---|
| Pelvic Neoplasms Endometriosis | Other: collection of sample and data |
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 Type : | Observational |
| Estimated 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 |
| Estimated Primary Completion Date : | August 2027 |
| Estimated Study Completion Date : | August 2037 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Collection of sample and data
Collection of biological samples and clinical data
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Other: collection of sample and data
Recovery of surgical waste during surgery planned in the current care and clinical data collection |
- circulating tumor and DNA [ Time Frame: 2 years ]
- Endometriosis tumor and DNA [ Time Frame: 2 years ]
- 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 ]
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03622983
| Contact: Cyril Touboul | 0156017000 ext +33 | cyril.touboul@gmail.com |
| France | |
| CHI Creteil | Recruiting |
| Créteil, France, 94000 | |
| Contact: Gregoire Miailhe, MD Gregoire.Miailhe@chicreteil.fr | |
| CHU Tenon | Recruiting |
| Paris, France, 75000 | |
| Contact: Cyril Touboul cyril.touboul@gmail.com | |
| Responsible Party: | Centre Hospitalier Intercommunal Creteil |
| ClinicalTrials.gov Identifier: | NCT03622983 |
| Other Study ID Numbers: |
PELVIMASS2 2016-A00613-48 ( Other Identifier: ID-RCB ) |
| First Posted: | August 9, 2018 Key Record Dates |
| Last Update Posted: | June 24, 2021 |
| Last Verified: | June 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Pelvic Neoplasms Endometriosis Neoplasms by Site Neoplasms |