Study of genetic predisposition to breast and ovarian cancer in individuals with BRCA mutations
Official title: Genetic Predisposition to Breast and Ovarian Cancer: Prospective Study of BRCAx Gene Mutation
Run by Institut Paoli-Calmettes · NCT03667417 · Data updated 2026-11-12
This study is trying to learn how having BRCA gene mutations affects the risk of breast and ovarian cancer in men and women aged 18 and older.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 5000 (estimated) |
| Sponsor | Institut Paoli-Calmettes Academic / other |
| Locations | 1 site (Marseille) |
| Status | Recruiting |
| Started | October 15, 1999 |
| Main results expected | October 15, 2028 |
| Study ends | October 15, 2028 |
| Registry record updated | October 14, 2026 |
| Trial ID | NCT03667417 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals aged 18 and over who carry a deleterious BRCA1 or BRCA2 mutation, regardless of whether they currently have cancer.
✕Probably not a fit
Patients who do not carry a BRCA mutation or those unable to provide informed consent may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on a cohort of individuals carrying deleterious BRCA1 or BRCA2 gene mutations to assess their genetic predispositions to breast and ovarian cancers. Participants, both men and women aged 18 and over, will complete questionnaires to gather data on their health and cancer history. The study aims to enhance understanding of how these genetic mutations influence cancer risk and outcomes. It will involve ongoing follow-up to monitor participants over time.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the cancer risks associated with BRCA mutations, potentially guiding prevention and treatment strategies.
How similar studies have gone: Other studies have shown success in understanding the implications of BRCA mutations, making this approach both relevant and supported by previous findings.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Institut Paoli-Calmettes
Marseille, France Recruiting
Study contacts
- Principal investigator: Catherine NOGUES, MD — Institut Paoli-Calmettes
- Study coordinator: Dominique GENRE, MD
- Email: DRCI.UP@ipc.unicancer.fr
- Phone: 33 491 22 37 78
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.