Women at Risk of Breast Cancer and OLFM4

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

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?

Study Overview

• Status: Active, not recruiting
• Conditions: Hereditary Breast and Ovarian Cancer Syndrome
• Intervention / Treatment: Biological: OLFM4

Detailed Description

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
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49055
    • Institut de Cancérologie de l'Ouest
  • Brest, France, 29000
    • CHU Morvan
  • Nantes, France, 44805
    • Instit de Cancérologie de l'Ouest
  • Vannes, France, 56000
    • CHBA Hopital Chubert

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OLFM4; Patient have a blood test every 6 months at the same time of the clinical exam planned in the following. The OLFM4 will be dose in the blood sample and the rate of OLFM4 compared to the result of imaging.	Biological: OLFM4; patient have an additional blood test every 6 months for dosing OLFM4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Every 6 months, up to 10 years (120 months)

Secondary Outcome Measures

Outcome Measure	Time Frame
The OLFM4 rate will be dosing by ELISA test in initial and followed blood sample of patient. This rate will be compared to the histology when it's possible.	5 years

Collaborators and Investigators

• Sponsor: Institut Cancerologie de l'Ouest
• Investigators: Principal Investigator: Paule AUGEREAU, MD, Institut de Cancérologie de l'Ouest - Angers

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2016
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: January 8, 2016
• First Submitted That Met QC Criteria: January 11, 2016
• First Posted (Estimated): January 12, 2016

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: High risk of cancer, BRCA1 or 2 mutation, Olfactomedine 4
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genetic Diseases, Inborn; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Skin Diseases; Breast Diseases; Neoplastic Syndromes, Hereditary; Breast Neoplasms; Ovarian Neoplasms; Hereditary Breast and Ovarian Cancer Syndrome
• Other Study ID Numbers: ICO-A-2014-05; 2014-A00305-42 (Other Identifier: French Institutional Ethical Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO