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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
First received
Last updated
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
Health authority
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

Study Design


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
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