BRCA Mutations in Latinas
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|ClinicalTrials.gov Identifier: NCT01251900|
Recruitment Status : Recruiting
First Posted : December 2, 2010
Last Update Posted : May 8, 2020
|First Submitted Date||December 1, 2010|
|First Posted Date||December 2, 2010|
|Last Update Posted Date||May 8, 2020|
|Actual Study Start Date||November 12, 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||Collection of saliva from 2000 probands [ Time Frame: Every six months ]|
|Original Primary Outcome Measures||Not Provided|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title||BRCA Mutations in Latinas|
|Official Title||BRCA1 and BRCA2 Mutations and Triple Negative Disease in Hispanic/Latino Breast Cancer Subjects|
- 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.
- 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.
|Study Design||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
|Study Population||All Hispanic women, over the age of 18, with breast cancer will be eligible.|
Hispanic women, over the age of 18, with breast cancer will be eligible.
|Publications *||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.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Estimated Enrollment||Same as current|
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
- Males and subjects under the age of 18.
|Ages||18 Years to 99 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||999911035
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )|
|Study Sponsor||National Cancer Institute (NCI)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||January 8, 2020|