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Recruiting NCT05835739

InheriteD brEast caNcer iTalian regIsTrY A Retrospective-prospective Observational Cohort Study to Evaluate Cancer Prevention Strategies in Women With a Deleterious Mutation in BRCA1-2

Trial Parameters

Condition Breast Cancer
Sponsor Centro di Riferimento Oncologico - Aviano
Study Type OBSERVATIONAL
Phase N/A
Enrollment 78
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2019-08-27
Completion 2025-09-30

Brief Summary

The purpose of the study is to obtain and centralize data about cancer prevention strategies in women with a germline deleterious mutation in BRCA1-2 with or without a history of breast cancer in Italy

Eligibility Criteria

Inclusion Criteria: Cohort A (Retrospective): 1. Female sex 2. Age ≥ 18 years 3. Signed informed consent 4. Documented germline deleterious mutation in BRCA1 and/or BRCA2 in people with: i) No history of cancer ii) Radically treated breast cancer iii) Stage IV breast cancer diagnosed after BRCA1-2 mutation detection 5. Admission to the participating Center since 1st of January 2010, prior to site activation Cohort B (Prospective): 1. Female sex 2. Age ≥ 18 years 3. Signed informed consent 4. Documented germline deleterious mutation in BRCA1 and/or BRCA2 in people with: i) No history of cancer ii) Radically treated breast cancer iii) Stage IV breast cancer diagnosed after BRCA1-2 mutation detection 5. Admission to the participating Center after site activation Exclusion Criteria: Cohort A/B (Retrospective/Prospective): 1\. Other malignancies diagnosed within five years prior to BRCA1-2 mutation detection, except for: * ovarian cancer stage I-II * basal or squamous cell carcinoma of the

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