Ignite Creation Date:
2024-05-05 @ 11:05 PM
Last Modification Date:
2024-10-26 @ 10:28 AM
Study NCT ID:
NCT01251900
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2010-12-01
Brief Title:
BRCA Mutations in Latinas
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
BRCA1 and BRCA2 Mutations and Triple Negative Disease in HispanicLatino Breast Cancer Subjects
Status:
COMPLETED
Status Verified Date:
2024-10-03
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:
None
Brief Summary:
Background
- BRCA1 and BRCA2 gene mutations have been linked to a higher risk of developing breast cancer and other cancers and may be associated with types of breast cancer that are more difficult to treat and more likely to recur New cancer treatments are being developed specifically to treat individuals who have these gene mutations However more information is needed about the prevalence of these mutations in minority populations including HispanicLatino populations To study these populations researchers are interested in collecting genetic material DNA and medical history information from HispanicLatino women who have been diagnosed with breast cancer
Objectives
- To collect saliva samples and medical and family history information from HispanicLatino women with breast cancer
Eligibility
- HispanicLatino women at least 18 years of age who have been diagnosed with breast cancer
Design
Participants will complete a questionnaire with information about place of birth languages spoken by parents and grandparents and information about their breast cancer diagnosis
Participants will provide a saliva sample 2 to 3 tablespoons for analysis
No treatment will be provided as part of this protocol
- BRCA1 and BRCA2 gene mutations have been linked to a higher risk of developing breast cancer and other cancers and may be associated with types of breast cancer that are more difficult to treat and more likely to recur New cancer treatments are being developed specifically to treat individuals who have these gene mutations However more information is needed about the prevalence of these mutations in minority populations including HispanicLatino populations To study these populations researchers are interested in collecting genetic material DNA and medical history information from HispanicLatino women who have been diagnosed with breast cancer
Objectives
- To collect saliva samples and medical and family history information from HispanicLatino women with breast cancer
Eligibility
- HispanicLatino women at least 18 years of age who have been diagnosed with breast cancer
Design
Participants will complete a questionnaire with information about place of birth languages spoken by parents and grandparents and information about their breast cancer diagnosis
Participants will provide a saliva sample 2 to 3 tablespoons for analysis
No treatment will be provided as part of this protocol
Detailed Description:
BACKGROUND
Mutations in the BRCA1 and BRCA2 genes predispose to breast and ovarian cancer and are increasingly recognized in prostate and pancreatic cancers
Basal Triple negative breast cancer is associated with BRCA mutations in some ethnicitiesHowever the link between BRCA gene mutations and Basil triple negative disease in Hispanic Latino women is not known
Common recurrent mutations in BRCA1 and BRCA2 exist in Hispanic Latino communities
New therapies such as PARP inhibitors may be particularly effective in BRCA mutation carriers
Therefore a unique opportunity exists to identify women in this underserved minority that may be eligible for and benefit from new targeted therapies
OBJECTIVES
- The primary objective is to collect saliva samples and histology data from up to 2000 Hispanic Latino subjects with breast cancer as a source of DNA and to analyze the BRCA1 and BRCA2 genes
ELIGIBILITY
- All Hispanics females over the age of 18 with breast cancer will be eligible
DESIGN
- Natural history study of 2000 HispanicLatino women with breast cancer 1000 with triple
negative disease 1000 without
Obtain clinical pathology reports and relevant history data on all subjects
Analyze recurrent BRCA1 and BRCA2 mutations
Mutations in the BRCA1 and BRCA2 genes predispose to breast and ovarian cancer and are increasingly recognized in prostate and pancreatic cancers
Basal Triple negative breast cancer is associated with BRCA mutations in some ethnicitiesHowever the link between BRCA gene mutations and Basil triple negative disease in Hispanic Latino women is not known
Common recurrent mutations in BRCA1 and BRCA2 exist in Hispanic Latino communities
New therapies such as PARP inhibitors may be particularly effective in BRCA mutation carriers
Therefore a unique opportunity exists to identify women in this underserved minority that may be eligible for and benefit from new targeted therapies
OBJECTIVES
- The primary objective is to collect saliva samples and histology data from up to 2000 Hispanic Latino subjects with breast cancer as a source of DNA and to analyze the BRCA1 and BRCA2 genes
ELIGIBILITY
- All Hispanics females over the age of 18 with breast cancer will be eligible
DESIGN
- Natural history study of 2000 HispanicLatino women with breast cancer 1000 with triple
negative disease 1000 without
Obtain clinical pathology reports and relevant history data on all subjects
Analyze recurrent BRCA1 and BRCA2 mutations
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11-C-N035 | None | None | None |