Women at Risk of Breast Cancer and OLFM4

  • STATUS
    Recruiting
  • End date
    Feb 24, 2026
  • participants needed
    300
  • sponsor
    Institut Cancerologie de l'Ouest
Updated on 2 March 2022
breast cancer
TP53
BRCA1

Summary

Does the olfactomdine provide an help to limit the number of false positives in the overall imaging balance and limit the number of unnecessary biopsies?

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 olfactomdine 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.

Details
Condition Hereditary Breast and Ovarian Cancer Syndrome
Treatment OLFM4
Clinical Study IdentifierNCT02653105
SponsorInstitut Cancerologie de l'Ouest
Last Modified on2 March 2022

Eligibility

Yes No Not Sure

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
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