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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03667417
Acronym
GENEPSO
Enrollment
5000
Registered
2018-09-12
Start date
1999-10-15
Completion date
2028-10-15
Last updated
2020-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancers, Ovarian Cancers

Keywords

BRCA gene 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

Interventions

OTHERQuestionnaires

standardized data collection and 10-year prospective follow-up

Sponsors

UNICANCER - Le Groupe génétique et cancer (GGC)
CollaboratorUNKNOWN
Institut Paoli-Calmettes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of breast and / or ovarian cancer during subject lifetime10 yearsrisk that a subject with a mutation develops breast and / or ovarian cancer during his lifetime, assessed by epidemiologic questionnaires (carcinologic events).

Countries

France

Contacts

Primary ContactDominique GENRE, MD
DRCI.UP@ipc.unicancer.fr33 491 22 37 78
Backup ContactMargot BERLINE, MSc, MBA
DRCI.UP@ipc.unicancer.fr33 491 22 33 14

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026