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
Recruiting · NCT05835739 · Observational (researchers observe without assigning treatment) · Lead sponsor: Centro di Riferimento Oncologico - Aviano
View the official record on ClinicalTrials.gov →What this trial is about
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 can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
12 locations listed.
- 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
- Centro di Riferimento Oncologico - Aviano - Aviano, Pordenone, Italy