Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
266 participants
OBSERVATIONAL
2011-07-07
Brief Summary
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\- 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.
Objectives:
\- To collect saliva samples and medical and family history information from Hispanic/Latino women with breast cancer.
Eligibility:
\- Hispanic/Latino 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
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* 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.
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 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
Conditions
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Keywords
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Patients
Hispanic women, over the age of 18, with breast cancer will be eligible.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients must have histologically or cytologically confirmed diagnosis of breast cancer.
* Age greater than or equal to 18 years.
* Ability to understand and the willingness to sign a written informed consent document.
* Must be willing and able to provide a saliva sample, answer questionnaire data online or complete a paper questionnaire, and request a copy of their pathology report.
Exclusion Criteria
18 Years
99 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Michael C Dean, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)
Locations
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Southwest Cancer Center, Lubbock; Texas Tech University
Lubbock, Texas, United States
Countries
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References
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Dean M, Boland J, Yeager M, Im KM, Garland L, Rodriguez-Herrera M, Perez M, Mitchell J, Roberson D, Jones K, Lee HJ, Eggebeen R, Sawitzke J, Bass S, Zhang X, Robles V, Hollis C, Barajas C, Rath E, Arentz C, Figueroa JA, Nguyen DD, Nahleh Z. Addressing health disparities in Hispanic breast cancer: accurate and inexpensive sequencing of BRCA1 and BRCA2. Gigascience. 2015 Nov 4;4:50. doi: 10.1186/s13742-015-0088-z. eCollection 2015.
Other Identifiers
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11-C-N035
Identifier Type: -
Identifier Source: secondary_id
999911035
Identifier Type: -
Identifier Source: org_study_id