Development of a Cinical and Biological Database in Ovarian, Fallopian Tube and Peritoneal Cancers (BCBOvaire)

February 11, 2025 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

Development of a Prospective and Monocentric Cinical and Biological Database in Epithelial Ovarian Cancer, Fallopian Tube Cancer and Primitive Peritoneal Cancer

A Clinical and Biological Database will provide to the scientific community a collection of blood and tissues with clinical datas to improve knowledge about cancer and help to develope new cancer treatments. This database is specific to epithetial ovarian cancer, Fallopian tube cancer and Primitive peritoneal cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A Clinical and Biological Database is a collection of reliable, prospective and representative datas.

This collection, provided to the scientific community, will help to develope research programs such as :

  • Cinicals and biological predictive factors of treatments response
  • Identification of biological tumoral markers associate with survival
  • Identification of prognosic factors after recidivism
  • Diagnostics tests optimisation and follow-up from blood samples ( Circulating Tumor Cells (CTC) )
  • Developing strong preclinical models. Those models would be later used to test alternative treatments and would help to identify new biomarkers

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 or older
  • Patient at the diagnosis of an epithelial ovarian cancer, or a fallopian tube caner or a primitive peritoneal cancer
  • Patient eligible for, at least, one surgery and a chemotherapy
  • Patient having given his informed, written and express consent

Exclusion Criteria:

  • Patient not affiliated to a social protection scheme
  • Pregnant and / or nursing women
  • Subject under tutelage, curatorship or safeguard of justice
  • Patient whose regular follow-up is impossible for psychological, familial, social or geographical reasons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biological collection

For all the patients include in the studie :

  • Blood samples collected at different times : Before treatment (T1) , after chemotherapy (T2), after interval surgery (T3) and after cancer reccurence (T4)
  • Tissue samples (tumor tissue and healthy tissue) collected during the surgery

In parallel to this biological collection, standardized clinical data will be entered into a database
Other: Biological collection
  • Blood samples collected at different times : Before treatment (T1) , after chemotherapy (T2), after interval surgery (T3) and after cancer reccurence (T4)
  • Tissue samples (tumor tissue and healthy tissue) collected during the surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who gave their consent to participate in the study
Time Frame: Until the study completion : 3 years
The proportion of patients who consent to participate in the study among the screened patients
Until the study completion : 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Principal Investigator: COLOMBO Pierre-Emmanuel, M.D, ICM - Institut régional du Cancer Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2017

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2032

Study Registration Dates

First Submitted

June 5, 2019

First Submitted That Met QC Criteria

June 5, 2019

First Posted (Actual)

June 6, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICM-BDD2016/04
  • 2016-A01041-50 (Registry Identifier: N° ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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