BRCA Mutations in Latinas

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01251900
First received: December 1, 2010
Last updated: May 15, 2014
Last verified: April 2014
  Purpose

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
Breast Neoplasms

Study Type: Observational
Official Title: BRCA1 and BRCA2 Mutations and Triple Negative Disease in Hispanic/Latino Breast Cancer Subjects

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 2000
Study Start Date: November 2010
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01251900

Contacts
Contact: Bert Gold, Ph.D. (301) 846-5098 golda@mail.nih.gov
Contact: Michael Dean, Ph.D. (301) 846-5931 dean@ncifcrf.gov

Locations
United States, Texas
Texas Tech University Health Sciences Center University Health Sciences Center Recruiting
El Paso, Texas, United States
Southwest Cancer Treatment and Research Center, Lubbock; Texas Tech University Recruiting
Lubbock, Texas, United States, 79415
Contact: Candy Arentz, M.D.    806-775-8600 ext 31886    candy.arentz@ttuhs.edu   
Sponsors and Collaborators
Investigators
Principal Investigator: Michael Dean, Ph.D. National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01251900     History of Changes
Other Study ID Numbers: 999911035, 11-C-N035
Study First Received: December 1, 2010
Last Updated: May 15, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Triple Negative Disease
BRCA1
BRCA2
Hispanic/Latino
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 21, 2014