Women at Risk of Breast Cancer and OLFM4

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?

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hereditary Breast and Ovarian Cancer Syndrome Adnexal Diseases Breast Diseases Breast Neoplasms Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Neoplastic Syndromes, Hereditary Ovarian Diseases Ovarian Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancerologie de l'Ouest, Angers, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OLFM4

Biological

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

Primary outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Registry information

Official study 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

Important dates

Study start: 2016
Primary completion: 2026
Study completion: 2026
First posted: Jan 12, 2016
Registry last updated: Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting