RECRUITINGOBSERVATIONAL
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
About This Trial
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
Who May Be Eligible (Plain English)
Who May Qualify:
Cohort A (Retrospective):
1. Female sex
2. Age ≥ 18 years
3. Signed willing to sign a consent form
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 willing to sign a consent form
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
Who Should NOT Join This Trial:
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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Locations (12)
Centro di Riferimento Oncologico - Aviano
Aviano, Pordenone, 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
Città della salute Torino, PO S. Anna
Torino, Italy
ASU FC Azienda Sanitaria Universitaria Friuli Centrale
Udine, Italy