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

Endometriosis Clinical Trial

— PELVIMASS2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03622983
• Other study ID #: PELVIMASS2
• Secondary ID: 2016-A00613-48
• Status: Recruiting
• Start date: May 1, 2017
• Est. completion date: August 2037

Study information

• Verified date: December 2022
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: Cyril Touboul
• Phone: 0156017000
• Email: cyril.touboul[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: August 2037
• Est. primary completion date: August 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis
• Pelvic Neoplasms

Intervention

Other:
• collection of sample and data
Recovery of surgical waste during surgery planned in the current care and clinical data collection

Locations

Country	Name	City	State
France	CHI Creteil	Créteil
France	CHU Tenon	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	circulating tumor and DNA		2 years
Primary	Endometriosis tumor and DNA		2 years
Secondary	circulating tumor DNA		5 years
Secondary	circulating tumor DNA		10 years
Secondary	circulating Micro RNA		2 years
Secondary	circulating Micro RNA		5 years
Secondary	circulating Micro RNA		10 years
Secondary	circulating cytokines		2 years
Secondary	circulating cytokines		5 years
Secondary	circulating cytokines		10 years
Secondary	Tumoral DNA		day of surgery