Measuring circulating mutation burden (cfMB) in women with BRCA mutations and their sisters
Official title: EVALUATION OF CANCER RISK BY MEASUREMENT OF CIRCULATING MUTATIONAL BURDEN IN CARRIERS OF A GENETIC PREDISPOSITION
Run by Centre Francois Baclesse · NCT06792721 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 30 Years to 50 Years |
| Sex | Women only |
| Enrollment | 30 (estimated) |
| Sponsor | Centre Francois Baclesse Academic / other |
| Locations | 1 site (Caen, France) |
| Status | Recruiting |
| Started | July 4, 2025 |
| Main results expected | July 15, 2029 |
| Study ends | December 30, 2029 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT06792721 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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: * Male gender * Current cancer or a history of cancer * Current smoker or someone who quit smoking less than 10 years ago with a cumulative exposure of \> 10 packs/year) * Presence of another hereditary predisposition to cancer * History of risk-reduction surgery (adnexectomy, fimbriectomy, mastectomy) * Chronic immunomodulatory treatment * Patients who are incarcerated, under legal guardianship, subject to a legal protective measure, or unable to give informed consent * Patients unable to participate in the study for geographic, social, or psychopathological reasons
Where it's running
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Centre François Baclesse
Caen, France, France Recruiting
Study contacts
- Study coordinator: Louise May THIBAUT, Medical Doctor
- Email: lm.thibaut@baclesse.unicancer.fr
- Phone: 0231455050
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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.