Genetic Predisposition to Breast and Ovarian Cancer: Prospective Study of BRCAx Gene Mutation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut Paoli-Calmettes
About this trial
Cohort of subjects carrying a BRCA gene mutation: genetic predispositions to breast and ovarian cancers
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Woman or man, with or without cancer, carrying a deleterious BRCA1/BRCA2 mutation, aged 18 years and over.
Woman with or without breast cancer or ovarian cancer at baseline.
Man with or without breast cancer at baseline.
Signed consent to participation
Disqualifiers
A person of legal age subject to a legal protection measure, or unable to express consent.
Impossibility to submit to the follow-up of the test for geographical, social or psychological reasons
Trial population
women and men with a BRCA1 or BRCA2 mutation
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Questionnaires
Other interventionstandardized data collection and 10-year prospective follow-up
Treatment groups
5,000 Participants
are divided into 1 treatment groupGroup A: subjects carrying a BRCA gene mutation1 intervention
Trial outcomes
Primary outcomes
1
Incidence of breast and / or ovarian cancer during subject lifetime
risk that a subject with a mutation develops breast and / or ovarian cancer during his lifetime, assessed by epidemiologic questionnaires (carcinologic events).
Time frame
10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Institut Paoli-Calmettes
Lead sponsor
UNICANCER - Le Groupe génétique et cancer (GGC)
Collaborator
Source ClinicalTrials.gov