Clinical Trial: Women at Risk of Breast Cancer and OLFM4
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
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
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 Summary:
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.
Sponsor: Institut Cancerologie de l'Ouest
Current Primary Outcome: 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 [ Time Frame: 5 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: 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. [ Time Frame: 5 years ]
Original Secondary Outcome: Same as current
Information By: Institut Cancerologie de l'Ouest
Dates:
Date Received: January 8, 2016
Date Started: February 2016
Date Completion: February 2026
Last Updated: January 11, 2016
Last Verified: January 2016
