Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05835739
Status:
RECRUITING
Last Update Posted:
2023-04-28
First Post:
2023-03-24
Brief Title:
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
Sponsor:
Centro di Riferimento Oncologico - Aviano
Organization:
Centro di Riferimento Oncologico - Aviano
Study Overview
Official Title:
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
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IDENTITY
Brief 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
Detailed Description:
Women who carry a deleterious mutation in breast cancer susceptibility gene 1 BRCA1 or breast cancer susceptibility gene 2 BRCA2 have an elevated lifetime risk of developing breast and ovarian cancer estimated at up to 7 and 25 times that of the average risk population respectively By the age of 80 years the estimated cumulative risk of breast cancer is about 70 for BRCA12 mutation carriers while the cumulative ovarian cancer risk is about 40 for BRCA1 and 20 for BRCA2 carriers Thus BRCA12 mutation carriers are advised to consider different risk-reducing strategies including surveillance breast self-examination clinical breast examination screening using mammography ultrasound and breast magnetic resonance imaging chemoprevention and prophylactic surgery prophylactic mastectomy andor salpingo-oophorectomy Prospective cohort studies demonstrate that risk-reducing mastectomy is associated with 90 or more decreased risk of breast cancer Unfortunately it is difficult to quantify its effect on overall mortality since no randomized studies have compared risk-reducing mastectomy with enhanced screening risk-reducing salpingo oophorectomy or prophylactic treatment Additionally prophylactic mastectomy is an invasive intervention associated with a substantial complication rate and psychological distress changes in body image and sexual function Therefore as a preventive measure risk-reducing mastectomy should be discussed on a case-by case basis after proper counseling regarding benefits limitations risks of surgical complications and psychosocial impact Conversely risk-reducing salpingo oophorectomy is strongly recommended for women with mutations in BRCA1 between ages 35 and 40 years and BRCA2 between ages 40 and 45 years after completion of childbearing desire for a significant reduction in ovarian cancer incidence and all-cause mortality In the absence of solid evidences coming from randomized clinical trials the aim of the present study is to collect and centralize real-world data on cancer prevention strategies prophylactic surgery prophylactic therapies active surveillance and oncologic treatments of women with a deleterious mutation in BRCA1-2 with or without a diagnosis of breast cancer in Italy By collecting and analyzing these data the IDENTITY study aims to obtain a faithful representation of the practices related to oncological surveillance in the group of patients analyzed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None