NCT03622983

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
137mo left

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
May 2017Aug 2037

Study Start

First participant enrolled

May 1, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2037

Last Updated

December 21, 2022

Status Verified

December 1, 2022

Enrollment Period

10.3 years

First QC Date

August 1, 2018

Last Update Submit

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

Other: collection of sample and data

Interventions

Recovery of surgical waste during surgery planned in the current care and clinical data collection

Collection of sample and data

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

RECRUITING

CHU Tenon

Paris, 75000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Biomarkers and tumoral samples

MeSH Terms

Conditions

Pelvic NeoplasmsEndometriosis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

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

Locations