Genetic Predisposition to Breast and Ovarian Cancer: Prospective Study of BRCAx Gene Mutation (GENEPSO)

June 30, 2020 updated by: Institut Paoli-Calmettes
Cohort of subjects carrying a BRCA gene mutation: genetic predispositions to breast and ovarian cancers

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cohort of subjects carrying a BRCA gene mutation: genetic predispositions to breast and ovarian cancers

Study Type

Observational

Enrollment (Anticipated)

5000

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 Contact Backup

Study Locations

  • France
      • Marseille, France, 13009
        • Recruiting
        • Institut Paoli-Calmettes
        • Contact:
        • Principal Investigator:
          • Catherine NOGUES, MD

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

women and men with a BRCA1 or BRCA2 mutation

Description

  1. Woman or man, with or without cancer, carrying a deleterious BRCA1/BRCA2 mutation, aged 18 years and over.

    1. Woman with or without breast cancer or ovarian cancer at baseline.
    2. Man with or without breast cancer at baseline.
  2. Signed consent to participation
  3. Affiliation to a social security regimen, or beneficiary of such a regimen.

Exclusion Criteria:

  1. A person of legal age subject to a legal protection measure, or unable to express consent.
  2. Impossibility to submit to the follow-up of the test for geographical, social or psychological 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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
subjects carrying a BRCA gene mutation
Other: Questionnaires
standardized data collection and 10-year prospective follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of breast and / or ovarian cancer during subject lifetime
Time Frame: 10 years
risk that a subject with a mutation develops breast and / or ovarian cancer during his lifetime, assessed by epidemiologic questionnaires (carcinologic events).
10 years

Collaborators and Investigators

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

Sponsor

Institut Paoli-Calmettes

Collaborators

UNICANCER - Le Groupe génétique et cancer (GGC)

Investigators

  • Principal Investigator: Catherine NOGUES, MD, Institut Paoli-Calmettes

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

Helpful Links

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)

October 15, 1999

Primary Completion (Anticipated)

October 15, 2028

Study Completion (Anticipated)

October 15, 2028

Study Registration Dates

First Submitted

September 10, 2018

First Submitted That Met QC Criteria

September 11, 2018

First Posted (Actual)

September 12, 2018

Study Record Updates

Last Update Posted (Actual)

July 1, 2020

Last Update Submitted That Met QC Criteria

June 30, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GENEPSO-IPC 2018-031

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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