BRCA Mutations in Latinas

NCT01251900 | Completed

• 2 other identifiers: 99991103511-C-N035
• Study Type: observational
• Target: 266
• Locations: 1 country
• Sites: 1

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 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....

Conditions

Breast Neoplasms

Keywords

Triple Negative Disease; BRCA1; BRCA2; Hispanic/Latino; Breast Cancer; Natural History

Outcome Measures

Primary Outcomes (1)

• Collection of saliva from 2000 probands

  Every six months

Study Arms (1)

Patients

Hispanic women, over the age of 18, with breast cancer will be eligible.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary clinical

You may qualify if:

• Patient must be self-identified of Hispanic/Latino origin.
• 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.

You may not qualify if:

• \- Males and subjects under the age of 18.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Southwest Cancer Center, Lubbock; Texas Tech University

Lubbock, Texas, 79415, United States

Location

Related Publications (1)

• 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.

  PMID: 26543556 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Michael C Dean, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 2, 2010
• Study Start: July 7, 2011
• Last Updated: June 8, 2026

Record last verified: 2025-09-25

Locations

US (1)