Measuring circulating mutation burden (cfMB) in women with BRCA mutations and their sisters
EVALUATION OF CANCER RISK BY MEASUREMENT OF CIRCULATING MUTATIONAL BURDEN IN CARRIERS OF A GENETIC PREDISPOSITION
This trial will test whether a blood test that measures circulating mutation burden (cfMB) differs between cancer-free women who carry a BRCA1/2 mutation and their non-carrier sisters.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 30 Years to 50 Years |
| Sex | Female |
| Sponsor | Centre Francois Baclesse Academic / other |
| Locations | 1 site (Caen, France) |
| Trial ID | NCT06792721 on ClinicalTrials.gov |
What this trial studies
This is an observational proof-of-concept study of sibling pairs in which one sister carries a BRCA1/2 mutation and the other does not. Both cancer-free sisters will provide blood samples for analysis of circulating mutation burden (cfMB). The trial compares cfMB results between the carrier and non-carrier within each pair to look for consistent differences linked to genetic predisposition. All participants are recruited from the oncogenetic follow-up program at Centre François Baclesse in Caen, France.
Who should consider this trial
Good fit: Ideal candidates are cancer-free women aged 30–50 who are under oncogenetic follow-up at Centre François Baclesse and belong to a biological sibling pair where one sister is a confirmed BRCA1/2 mutation carrier and the other is not, and who consent to participate.
Not a fit: Women who are outside the 30–50 age range, who already have a cancer diagnosis, who are not part of an eligible sibling pair, or who are not followed at Centre François Baclesse are unlikely to benefit from this specific protocol.
Why it matters
Potential benefit: If successful, the test could provide a noninvasive way to monitor mutation-related signals in the blood and help guide risk monitoring in BRCA mutation carriers.
How similar studies have performed: Circulating tumor DNA and related mutation-burden methods have shown promise in detecting cancer in symptomatic patients, but applying cfMB for risk monitoring in asymptomatic BRCA carriers is relatively novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female participant * Participant undergoing oncogenetic follow-up at the Centre François Baclesse * Participant belonging to a pair of related biological siblings * Within the sibling pair, one participant is a carrier of a hereditary predisposition linked to a BRCA1/2 mutation (case), and the other participant is not a carrier (control). * Participant between 30 and 50 years of age * Participant affiliated to a social security scheme * Participant having given her consent to participate by signing an informed consent form prior to any specific study-related procedure. Exclusion Criteria: \-
Where this trial is running
Caen, France
- Centre François Baclesse — Caen, France, France (Recruiting)
Study contacts
- Study coordinator: Louise May THIBAUT, Medical Doctor
- Email: lm.thibaut@baclesse.unicancer.fr
- Phone: 0231455050
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.