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Clinical Trials in France / NCT02653105
Active, not recruiting Not applicable

Women at Risk of Breast Cancer and OLFM4

NCT02653105 · tracked via the Priya Life Science France tracker
Sponsor
Institut Cancerologie de l'Ouest
Phase
Not applicable
Started
2016-03-08
Last updated
2025-08-15

Condition(s) studied

Hereditary Breast and Ovarian Cancer Syndrome

Investigational drug(s) / intervention(s)

OLFM4

OLFM4: patient have an additional blood test every 6 months for dosing OLFM4

Study summary

Does the olfactomédine provide an help to limit the number of false positives in the overall imaging balance and limit the number of unnecessary biopsies?

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age \> or = 18 years * High risk women of breast cancer occurrence defined by the following criteria: * Women carrying a genetic mutation BRCA1 or 2 or TP53, entering or already in screening breast IRM * Women with a high probability of hereditary predisposition to breast cancer (20% risk at 70 years of breast cancer by BOADICEA model), assessed by the onco-geneticists * Information of the person and signing the informed consent Exclusion Criteria: * Women with a history of breast cancer or in situ * Person who is not affiliated to a social security scheme or beneficiary of such a regime

Primary outcome measure(s)

  • Predictive value of circulating OLFM4 in BRCA1/2 mutation carriers or high-risk women with positive breast imaging — Every 6 months, up to 10 years (120 months)
    The primary objective is to determine the positive predictive value of serum OLFM4 levels in women who are BRCA1 or BRCA2 mutation carriers, or considered at high risk for breast cancer, and who present with a positive imaging workup (including MRI, mammography, and ultrasound) leading to biopsy. The study aims to assess whether OLFM4 can help reduce false positives from imaging and thereby limit unnecessary biopsies. Blood samples will be collected every 6 months over a 10-year period.

Trial sites (4)

FacilityCityRegionStatus
Institut de Cancerologie de l'Ouest Angers France
CHU Morvan Brest France
Instit de Cancérologie de l'Ouest Nantes France
CHBA Hopital Chubert Vannes France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02653105 on ClinicalTrials.gov ↗ ← All trials in France