Clinical trial NCT03667417: Genetic Predisposition to Breast and Ovarian Cancer: Prospective Study of BRCAx Gene Mutation
Official title: Genetic Predisposition to Breast and Ovarian Cancer: Prospective Study of BRCAx Gene Mutation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancers
Ovarian Cancers
Keywords: BRCA gene mutation
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
Collaborators: name: UNICANCER - Le Groupe génétique et cancer (GGC)
First posted: 2018-09-12
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women and men with a BRCA1 or BRCA2 mutation

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of breast and / or ovarian cancer during subject lifetime
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
Study officials:
affiliation: Institut Paoli-Calmettes
name: Catherine NOGUES, MD
role: PRINCIPAL_INVESTIGATOR
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