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

Breast Cancers Clinical Trial

— GENEPSO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03667417
• Other study ID #: GENEPSO-IPC 2018-031
• Status: Recruiting
• Start date: October 15, 1999
• Est. completion date: October 15, 2028

Study information

• Verified date: June 2020
• Source: Institut Paoli-Calmettes
• Contact: Dominique GENRE, MD
• Phone: 33 491 22 37 78
• Email: DRCI.UP[@]ipc.unicancer.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: October 15, 2028
• Est. primary completion date: October 15, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancers
• Carcinoma, Ovarian Epithelial
• Disease Susceptibility
• Genetic Predisposition to Disease
• Ovarian Cancers
• Ovarian Neoplasms

Intervention

Other:
• Questionnaires
standardized data collection and 10-year prospective follow-up

Locations

Country	Name	City	State
France	Institut Paoli-Calmettes	Marseille

Sponsors (2)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes	UNICANCER - Le Groupe génétique et cancer (GGC)

Country where clinical trial is conducted

France, 

References & Publications (59)

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* Note: There are 59 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	10 years

External Links

•   Description de la cohorte GENEPSO au sein du Portail Epidémiologie-France