Women at Risk of Breast Cancer and OLFM4

N/AActive Not RecruitingNCT02653105

Institut Cancerologie de l'Ouest150 enrolled

Overview

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?

About 5% of breast cancers are associated with the presence of a constitutional genetic alteration. Two genes are being studied: BRCA1 and BRCA2. The national program for breast cancer screening target women 50 to 74 years but does not include women with significant risk factors. However in identifiable risk situations, breast cancer incidence is increased: and it affects 1 in 4 women with certain risk histological lesions and more than 1 in 2 women carrying a mutation in the BRCA1 or BRCA2 gene. Studies have shown that the olfactomédine 4 (OLFM4) is highly overexpressed in tumors compared to healthy tissue. The OLFM4 might therefore be a marker for early detection of breast cancer. We wish to determine the positive predictive value of OLFM4 seric dosing of patients at risk with respect to imaging.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

150

Conditions

Hereditary Breast and Ovarian Cancer Syndrome

Interventions

OLFM4BIOLOGICAL

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

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

Outcomes

Primary Outcomes

Predictive value of circulating OLFM4 in BRCA1/2 mutation carriers or high-risk women with positive breast imaging

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.

Time frame: Every 6 months, up to 10 years (120 months)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.