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Recruiting Observational

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

NCT05835739 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2019-08-27
Last updated
2023-04-28

Condition(s) studied

Breast Cancer

Study 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
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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 skin * melanoma in situ * CIS of the cervix

Primary outcome measure(s)

  • 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 — 10 years since enrolment
    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

Trial sites (12)

FacilityCityRegionStatus
Centro di Riferimento Oncologico - Aviano Aviano Pordenone Recruiting
IRCCS AOU San Martino, IST Genova Genova Italy Recruiting
Azienda Ospedaliera Papardo Messina Italy Recruiting
ASST Ovest Milanese Milan Italy Recruiting
Azienda ospedaliera Universitaria di Modena Modena Italy Recruiting
Università degli studi di Napoli Federico II Naples Italy Recruiting
Azienda AUSL IRCCS - Reggio Emilia Reggio Emilia Italy Recruiting
ASL Roma 1, Santo Spirito Roma Italy Recruiting
IFO - Istituto Regina Elena (Oncologia medica 2) Roma Italy Recruiting
Policlinico Universitario Gemelli Roma Italy Recruiting
Città della salute Torino, PO S. Anna Torino Italy Recruiting
ASU FC Azienda Sanitaria Universitaria Friuli Centrale Udine Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05835739 on ClinicalTrials.gov ↗ ← All trials in Italy