Study of genetic predisposition to breast and ovarian cancer in individuals with BRCA mutations
Genetic Predisposition to Breast and Ovarian Cancer: Prospective Study of BRCAx Gene Mutation
Institut Paoli-Calmettes · NCT03667417
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 |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Paoli-Calmettes (other) |
| Locations | 1 site (Marseille) |
| Trial ID | NCT03667417 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who do not carry a BRCA mutation or those unable to provide informed consent may not benefit from this study.
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 performed: Other studies have shown success in understanding the implications of BRCA mutations, making this approach both relevant and supported by previous findings.
Eligibility criteria
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 this trial is running
Marseille
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancers, Ovarian Cancers, BRCA gene mutation