Recruiting
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
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
ClinicalTrials.gov IDNCT05835739
PhaseNot Applicable
Enrollment78
SponsorCentro di Riferimento Oncologico - Aviano
Age18 Years and older
SexFEMALE
Conditions studied
Breast Cancer
About this study
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
Primary outcomes
- 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)
Eligibility information
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
Study locations
- Centro di Riferimento Oncologico - Aviano, Aviano, Pordenone 33081 Italy
- IRCCS AOU San Martino, IST Genova, Genova, Italy
- Azienda Ospedaliera Papardo, Messina, Italy
- ASST Ovest Milanese, Milan, Italy
- Azienda ospedaliera Universitaria di Modena, Modena, Italy
- Università degli studi di Napoli Federico II, Naples, Italy
- Azienda AUSL IRCCS - Reggio Emilia, Reggio Emilia, Italy
- ASL Roma 1, Santo Spirito, Roma, Italy
- IFO - Istituto Regina Elena (Oncologia medica 2), Roma, Italy
- Policlinico Universitario Gemelli, Roma, Italy
Showing 10 of 12 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-19.