BRCA Mutations in Latinas

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT01251900
Collaborator
(none)
266
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 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

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    266 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    BRCA1 and BRCA2 Mutations and Triple Negative Disease in Hispanic/Latino Breast Cancer Subjects
    Actual Study Start Date :
    Jul 7, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    Patients

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

    Outcome Measures

    Primary Outcome Measures

    1. Collection of saliva from 2000 probands [Every six months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    • INCLUSION CRITERIA:

    • 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.

    EXCLUSION CRITERIA:
    • Males and subjects under the age of 18.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Southwest Cancer Center, Lubbock; Texas Tech University Lubbock Texas United States 79415

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Michael Dean, Ph.D., National Cancer Institute (NCI)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT01251900
    Other Study ID Numbers:
    • 999911035
    • 11-C-N035
    First Posted:
    Dec 2, 2010
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Dec 6, 2021
    Keywords provided by National Cancer Institute (NCI)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 12, 2022