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Biomarkers for Breast Cancer Risk in African American Women

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ClinicalTrials.gov Identifier: NCT01736306
Recruitment Status : Completed
First Posted : November 29, 2012
Last Update Posted : October 19, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:


- 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.


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


- 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.


  • 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 or disease
Breast Cancer

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Epigenetics and Breast Cancer Risk in African American Women
Study Start Date : July 23, 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. breast cancer biomarkers [ Time Frame: various time points throughout study conduct ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01736306

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

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01736306     History of Changes
Other Study ID Numbers: 999912132
First Posted: November 29, 2012    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: April 6, 2017

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

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