Women at Risk of Breast Cancer and OLFM4

Sponsor

Institut Cancerologie de l'Ouest (Other)

Overall Status

Recruiting

CT.gov ID

NCT02653105

Collaborator

(none)

300

Enrollment

Locations

Arm

118.8

Anticipated Duration (Months)

37.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Hereditary Breast and Ovarian Cancer Syndrome	Biological: OLFM4	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

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

Actual Study Start Date :

Mar 8, 2016

Anticipated Primary Completion Date :

Feb 1, 2026

Anticipated Study Completion Date :

Feb 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Biological: OLFM4 patient have an additional blood test every 6 months for dosing OLFM4

Arm

Intervention/Treatment

Experimental: 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.

Biological: OLFM4

patient have an additional blood test every 6 months for dosing OLFM4

Outcome Measures

Primary Outcome Measures

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 [5 years]

Secondary Outcome Measures

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. [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Institut de Cancerologie de l'Ouest	Angers	France	49055
2	CHU Morvan	Brest	France	29000
3	CH	Cholet	France	49300
4	CH	Le Mans	France	72037
5	Instit de Cancérologie de l'Ouest	Nantes	France	44805
6	CHU La Mileterie	Poitiers	France	86021
7	CHU Bretonneau	Tours	France	37000
8	CHBA Hopital Chubert	Vannes	France	56000

Sponsors and Collaborators

Institut Cancerologie de l'Ouest

Investigators

Principal Investigator: Paule AUGEREAU, MD, Institut de Cancérologie de l'Ouest - ANGERS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institut Cancerologie de l'Ouest

ClinicalTrials.gov Identifier:

NCT02653105

Other Study ID Numbers:

ICO-A-2014-05
2014-A00305-42

First Posted:

Jan 12, 2016

Last Update Posted:

Mar 24, 2020

Last Verified:

Mar 1, 2020

Keywords provided by Institut Cancerologie de l'Ouest

High risk of cancer, BRCA1 or 2 mutation, Olfactomedine 4

Additional relevant MeSH terms:

Hereditary Breast and Ovarian Cancer Syndrome

Study Results

No Results Posted as of Mar 24, 2020