MEASUREMENT OF CIRCULATING MUTATION BURDEN

NCT ID: NCT06792721

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-04

Study Completion Date

2027-12-30

Brief Summary

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Cancer-free women with a hereditary predisposition to breast and/or ovarian cancer

Detailed Description

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This proof-of-concept trial will be conducted with family members being monitored for a predisposition to breast and/or ovarian cancer linked to a BRCA1/2 gene mutation.

The study will be proposed to two sisters from the same sibling:

* one is a carrier of the genetic mutation
* and the other not,

Blood tests will evaluate the Mutation Burden cfMB

Conditions

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Breast Carcinoma Genetic Predisposition to Cancer BRCA Mutation cfMB Mutation Burden

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

PROSPECTIVE

Study Groups

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Case group

participant with a hereditary predisposition linked to a BRCA1/2 mutation (case)

Mutation Burden cfMB analysis

Intervention Type GENETIC

Blood samples will be collected (one time only)

Control group

participant not carrying a hereditary predisposition linked to a BRCA1/2 mutation (control) participant from the same sibling as the carrier participant (sister)

Mutation Burden cfMB analysis

Intervention Type GENETIC

Blood samples will be collected (one time only)

Interventions

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Mutation Burden cfMB analysis

Blood samples will be collected (one time only)

Intervention Type GENETIC

Eligibility Criteria

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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

\-
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Francois Baclesse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre François Baclesse

Caen, France, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Louise May THIBAUT, Medical Doctor

Role: CONTACT

0231455050

Facility Contacts

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Louise May THIBAUT, MD

Role: primary

Other Identifiers

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2024-A02540-47

Identifier Type: -

Identifier Source: org_study_id

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