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

Status: Recruiting
Location: See all (12) locations...
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Italy
Centro di Riferimento Oncologico - Aviano
RECRUITING
Aviano
IRCCS AOU San Martino, IST Genova
RECRUITING
Genova
Azienda Ospedaliera Papardo
RECRUITING
Messina
ASST Ovest Milanese
RECRUITING
Milan
Azienda ospedaliera Universitaria di Modena
RECRUITING
Modena
Università degli studi di Napoli Federico II
RECRUITING
Napoli
Azienda AUSL IRCCS - Reggio Emilia
RECRUITING
Reggio Emilia
ASL Roma 1, Santo Spirito
RECRUITING
Roma
IFO - Istituto Regina Elena (Oncologia medica 2)
RECRUITING
Roma
Policlinico Universitario Gemelli
RECRUITING
Roma
Città della salute Torino, PO S. Anna
RECRUITING
Torino
ASU FC Azienda Sanitaria Universitaria Friuli Centrale
RECRUITING
Udine
Time Frame
Start Date: 2019-08-27
Estimated Completion Date: 2035-09-30
Participants
Target number of participants: 78
Treatments
Cohort A (Retrospective)
all consecutive women with a germline deleterious mutation in BRCA1-2 admitted to the participant Center since 1st of January 2010 until site activation will be enrolled
Cohort B (Prospective):
all consecutive women with a germline deleterious mutation in BRCA1-2 admitted to the participant Center since site activation until September 2025 will be enrolled
Related Therapeutic Areas
Sponsors
Leads: Centro di Riferimento Oncologico - Aviano

This content was sourced from clinicaltrials.gov