Women at Risk of Breast Cancer and OLFM4

NCT02653105 | Active Not Recruiting

• 2 other identifiers: ICO-A-2014-052014-A00305-42
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 4

Brief Summary

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?

Conditions

Hereditary Breast and Ovarian Cancer Syndrome

Keywords

High risk of cancer, BRCA1 or 2 mutation, Olfactomedine 4

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

OLFM4

EXPERIMENTAL

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

Interventions

OLFM4 BIOLOGICAL

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

OLFM4

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (4)

Institut de Cancerologie de l'Ouest

Angers, 49055, France

Location

CHU Morvan

Brest, 29000, France

Location

Instit de Cancérologie de l'Ouest

Nantes, 44805, France

Location

CHBA Hopital Chubert

Vannes, 56000, France

Location

MeSH Terms

Conditions

Hereditary Breast and Ovarian Cancer Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Paule AUGEREAU, MD

  Institut de Cancérologie de l'Ouest - ANGERS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: January 12, 2016
• Study Start: March 8, 2016
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)