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
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?
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Institut Cancerologie de l'Ouest |
France,
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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