BRCA Mutations in Latinas
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01251900|
Recruitment Status : Recruiting
First Posted : December 2, 2010
Last Update Posted : February 15, 2019
- 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 Hispanic/Latino populations. To study these populations, researchers are interested in collecting genetic material (DNA) and medical history information from Hispanic/Latino women who have been diagnosed with breast cancer.
- To collect saliva samples and medical and family history information from Hispanic/Latino women with breast cancer.
- Hispanic/Latino women at least 18 years of age who have been diagnosed with breast cancer.
- 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.
|Condition or disease|
- 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 ethnicities.However 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.
- 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..
- All Hispanics females, over the age of 18, with breast cancer will be eligible.
- Natural history study of 2000 Hispanic/Latino 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 Type :||Observational|
|Estimated Enrollment :||2000 participants|
|Official Title:||BRCA1 and BRCA2 Mutations and Triple Negative Disease in Hispanic/Latino Breast Cancer Subjects|
|Actual Study Start Date :||November 12, 2010|
Hispanic women, over the age of 18, with breast cancer will be eligible.
- Collection of saliva from 2000 probands [ Time Frame: Every six months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01251900
|Contact: Michael Dean, Ph.D.||(240) email@example.com|
|United States, Texas|
|Southwest Cancer Center, Lubbock; Texas Tech University||Recruiting|
|Lubbock, Texas, United States, 79415|
|Contact: Catherine Jones, MD 806-775-8590 Catherine.firstname.lastname@example.org|
|Principal Investigator:||Michael Dean, Ph.D.||National Cancer Institute (NCI)|