Assessing OLFM4 for breast cancer risk management in women
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Institut Cancerologie de l'Ouest Academic / other |
| Locations | 8 sites (Angers and 7 other locations) |
| Trial ID | NCT02653105 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with a BRCA1 or BRCA2 mutation or a high probability of hereditary breast cancer.
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.
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 performed: Previous studies have indicated that OLFM4 is overexpressed in tumors, suggesting potential for success in this novel approach.
Eligibility criteria
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 this trial is running
Angers and 7 other locations
- Institut de Cancerologie de l'Ouest — Angers, France (Not_yet_recruiting)
- CHU Morvan — Brest, France (Not_yet_recruiting)
- Ch — Cholet, France (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)
- 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
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.