Clinical Trials in Italy / NCT05835739
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
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Centro di Riferimento Oncologico - Aviano trials in Italy
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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