Biomarkers for Breast Cancer Risk in African American Women

Completed

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT01736306

Run by

National Cancer Institute (NCI)

People needed

260

Starts

2012-07-23

Expected to finish

2020-03-27

Last updated by the study team

2020-03-31

Who can join

Age: 10 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• University of Massachusetts — Worcester, Massachusetts, United States

Full record on ClinicalTrials.gov

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