RecruitingNCT05835739
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
Sponsor
Centro di Riferimento Oncologico - Aviano
Enrollment
78 participants
Start Date
Aug 27, 2019
Study Type
OBSERVATIONAL
Conditions
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
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria12
- Cohort A (Retrospective):
- Female sex
- Age ≥ 18 years
- Signed informed consent
- 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
- Admission to the participating Center since 1st of January 2010, prior to site activation
- Cohort B (Prospective):
- Female sex
- Age ≥ 18 years
- Signed informed consent
- 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
- Admission to the participating Center after site activation
Exclusion Criteria6
- Cohort A/B (Retrospective/Prospective):
- \. 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 skin
- melanoma in situ
- CIS of the cervix
Locations(12)
View Full Details on ClinicalTrials.gov
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NCT05835739
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