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Biomarkers for Breast Cancer Risk in African American Women

NCT01736306 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 260

Last updated 2020-03-31

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Gretchen Benson, Ph.D. · National Cancer Institute (NCI)

Eligibility

Min Age
10 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-23
Primary Completion
2020-02-20
Completion
2020-03-27

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01736306 on ClinicalTrials.gov