Biomarkers for Breast Cancer Risk in African American Women

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:
NCT01736306
First received: November 27, 2012
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

Background:

- At present, women do not have very accurate tests to inform of them of their personal risk of developing breast cancer. More information on the changes associated with both benign and cancerous breast lesions will help develop better risk information. Researchers have been looking at cells found in breast milk to study genetic changes related to breast cancer. However, most of these cell samples have been collected from white women. A new study wants to collect breast milk samples from African American women for further research. Comparing the results of genetic tests will help improve understanding of breast cancer risk in all women.

Objectives:

- To study genetic changes related to breast lesions, including breast cancer, in African American women.

Eligibility:

- African American women at least 18 years of age who are nursing a baby and who either have had or are being considered for a breast biopsy.

Design:

  • Participants will be screened with personal health questions.
  • Participants will receive a box with sterile bottles for milk collection. They will collect two breast milk samples, one from each breast. They will also fill out a questionnaire about their medical history.
  • The box with the samples and the questionnaire will be returned to the clinical center for study.
  • After the box is returned, participants will be asked to provide a copy of the biopsy report for any breast biopsies they have had.
  • There will be a followup phone call every year. Participants will provide health history information. This information will include whether they have been diagnosed with breast cancer in the previous year.

Condition
Breast Cancer

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Epigenetics and Breast Cancer Risk in African American Women

Resource links provided by NLM:


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

Primary Outcome Measures:
  • breast cancer biomarkers [ Time Frame: various time points throughout study conduct ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: July 2012
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   10 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:
  • Any woman who identifies as African American, Black, or African
  • Currently nursing a baby
  • Able and willing to sign written informed consent
  • Willing to be contacted by study personnel for follow-up to determine whether a biopsy took place
  • Willing to have her milk sample archived for future analyses

EXCLUSION CRITERIA:

  • The woman does not consider herself to be of African American, Black, or African. These women may participate in the other ongoing Breast Milk Study at University of Massachusetts.
  • Unable to sign written Informed Consent or Assent Form.
  • Unwilling to be contacted by study personnel.
  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: NCT01736306

Contacts
Contact: Gretchen Benson, Ph.D. (301) 594-5635 gierachg@mail.nih.gov

Locations
United States, Massachusetts
University of Massachusetts Recruiting
Worcester, Massachusetts, United States, 01655-0331
Sponsors and Collaborators
Investigators
Principal Investigator: Gretchen Benson, Ph.D. National Cancer Institute (NCI)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01736306     History of Changes
Other Study ID Numbers: 999912132, 12-C-N132
Study First Received: November 27, 2012
Last Updated: April 23, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Breast Cancer
Breast Milk
Epigenetics

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

ClinicalTrials.gov processed this record on September 22, 2014