Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
150 participants
INTERVENTIONAL
2016-03-08
2026-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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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.
OLFM4
patient have an additional blood test every 6 months for dosing OLFM4
Interventions
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OLFM4
patient have an additional blood test every 6 months for dosing OLFM4
Eligibility Criteria
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Inclusion Criteria
* 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
* Person who is not affiliated to a social security scheme or beneficiary of such a regime
18 Years
FEMALE
No
Sponsors
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Institut Cancerologie de l'Ouest
OTHER
Responsible Party
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Principal Investigators
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Paule AUGEREAU, MD
Role: PRINCIPAL_INVESTIGATOR
Institut de Cancérologie de l'Ouest - ANGERS
Locations
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Institut de Cancerologie de l'Ouest
Angers, , France
CHU Morvan
Brest, , France
Instit de Cancérologie de l'Ouest
Nantes, , France
CHBA Hopital Chubert
Vannes, , France
Countries
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Other Identifiers
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2014-A00305-42
Identifier Type: OTHER
Identifier Source: secondary_id
ICO-A-2014-05
Identifier Type: -
Identifier Source: org_study_id
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