Women at Risk of Breast Cancer and OLFM4

Institut Cancerologie de l'Ouest

Status: Active, not recruiting

Conditions: Hereditary Breast and Ovarian Cancer Syndrome

Treatments: Biological: OLFM4

Study type: Interventional

Funder types: Other

Identifiers

NCT02653105

2014-A00305-42 (Other Identifier)

ICO-A-2014-05

Details and patient eligibility

About

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?

Full 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.

Enrollment: 150 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

OLFM4

Experimental group

Description:

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.

Treatment:

Biological: OLFM4