Women at Risk of Breast Cancer and OLFM4

Hereditary Breast and Ovarian Cancer Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02653105
• Other study ID #: ICO-A-2014-05
• Secondary ID: 2014-A00305-42
• Status: Recruiting
• Phase: N/A
• Start date: March 8, 2016
• Est. completion date: February 2026

Study information

• Verified date: March 2020
• Source: Institut Cancerologie de l'Ouest
• Contact: Magali BALAVOINE
• Phone: 2 41 35 29 31
• Email: magali.balavoine[@]ico.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hereditary Breast and Ovarian Cancer Syndrome

Intervention

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

Locations

Country	Name	City	State
France	Institut de Cancerologie de l'Ouest	Angers
France	CHU Morvan	Brest
France	CH	Cholet
France	CH	Le Mans
France	Instit de Cancérologie de l'Ouest	Nantes
France	CHU La Mileterie	Poitiers
France	CHU Bretonneau	Tours
France	CHBA Hopital Chubert	Vannes

Sponsors (1)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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