Assessing OLFM4 for breast cancer risk management in women
Official title: Evaluation of the Circulating Concentration of Olfactomédine 4 (OLFM4) in Women With a BRCA1 or 2 Gene Mutation or at High Risk of Developing Breast Cancer, According to the Imaging
Run by Institut Cancerologie de l'Ouest · NCT02653105 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing if measuring a protein called OLFM4 can help women at high risk for breast cancer get better early detection and avoid unnecessary biopsies.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 300 (estimated) |
| Sponsor | Institut Cancerologie de l'Ouest Academic / other |
| Locations | 8 sites (Angers and 7 other locations) |
| Trial ID | NCT02653105 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 and older with a BRCA1 or BRCA2 mutation or a high probability of hereditary breast cancer.
✕Probably not a fit
Patients with a history of breast cancer or those not affiliated with a social security scheme may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the role of olfactomedine 4 (OLFM4) as a potential biomarker for early detection of breast cancer in women at high risk due to genetic factors such as BRCA1 or BRCA2 mutations. The research aims to evaluate whether OLFM4 can help reduce false positives in imaging results and minimize unnecessary biopsies. Participants will include women aged 18 and older who meet specific criteria for hereditary breast cancer risk. The study will involve measuring OLFM4 levels in serum to determine its predictive value in conjunction with imaging techniques.
Why it matters
Potential benefit: If successful, this study could lead to more accurate breast cancer screening and fewer unnecessary procedures for high-risk women.
How similar studies have gone: Previous studies have indicated that OLFM4 is overexpressed in tumors, suggesting potential for success in this novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Ch
Cholet, France Recruiting -
Institut de Cancerologie de l'Ouest
Angers, France Not yet recruiting -
CHU Morvan
Brest, France Not yet recruiting -
Ch
Le Mans, France Not yet recruiting -
Instit de Cancérologie de l'Ouest
Nantes, France Not yet recruiting -
CHU La Mileterie
Poitiers, France Not yet recruiting
Show 2 more locations
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CHU Bretonneau
Tours, France Not yet recruiting -
CHBA Hopital Chubert
Vannes, France Not yet recruiting
Study contacts
- Principal investigator: Paule AUGEREAU, MD — Institut de Cancérologie de l'Ouest - ANGERS
- Study coordinator: Magali BALAVOINE
- Email: magali.balavoine@ico.unicancer.fr
- Phone: 2 41 35 29 31
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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.