Clinical trial NCT02653105: Women at Risk of Breast Cancer and OLFM4
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hereditary Breast and Ovarian Cancer Syndrome
Keywords: High risk of cancer, BRCA1 or 2 mutation, Olfactomedine 4
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2016-01-12
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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?

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.

Eligibility criteria: 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

Primary outcomes:
measure: The OLFM4 rate will be dosing by ELISA test in initial and followed blood sample of patient. This rate will be compared to the imaging to determine the positive predictive value of the assay OLFM4
timeFrame: 5 years
Secondary outcomes:
measure: 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.
timeFrame: 5 years
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancerologie de l'Ouest
city: Brest
country: France
facility: CHU Morvan
city: Cholet
country: France
facility: CH
city: Le Mans
country: France
facility: CH
city: Nantes
country: France
facility: Instit de Cancérologie de l'Ouest
city: Poitiers
country: France
facility: CHU La Mileterie
city: Tours
country: France
facility: CHU Bretonneau
city: Vannes
country: France
facility: CHBA Hopital Chubert
Study officials:
affiliation: Institut de Cancérologie de l'Ouest - ANGERS
name: Paule AUGEREAU, MD
role: PRINCIPAL_INVESTIGATOR
References: