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Epigenetic Testing for Breast Cancer Risk Stratification

NCT01501656 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 158

Last updated 2016-06-01

No results posted yet for this study

Summary

Promoter region hypermethylation of tumor suppressor genes is one the earliest molecular events in malignant transformation and is readily detectable in apparently normal benign breast epithelium adjacent to breast cancers. The investigators hypothesize that DNA methylation of certain genes occurs as a field change in benign breast tissue that is at high risk for malignant transformation, and as such, can be exploited for tissue-based breast cancer risk stratification. Additional work is required to identify new DNA methylation markers potentially useful for periareolar fine needle aspiration (RP-FNA)-based breast cancer risk stratification, to determine whether these markers are methylated more frequently in benign samples from women who develop breast cancer, to determine whether assessment of these markers is reproducible, to determine whether tamoxifen reduces DNA methylation, and to better understand the pattern of DNA methylation in benign samples from unselected healthy control populations. Each of these objectives contributes to advancement of a clinically useful RP-FNA-based breast cancer risk stratification test.

In addition, identification of genes that are preferentially methylated in estrogen receptor (ER) negative breast cancer will provide clues to the underlying biology responsible for this aggressive form of breast cancer. This knowledge may lead to the discovery of the causes of ER negative breast cancer, approaches for recognizing women at increased risk for this type of breast cancer, and approaches for reducing this risk.

This study seeks to identify patterns of DNA methylation in benign breast epithelial cells associated with an increased risk for breast cancer with a focus on ER negative breast cancer.

Conditions

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Rolf Brekken, MD · UT Southwetstern Medical Center

Eligibility

Min Age
30 Years
Max Age
79 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-11-30
Completion
2014-11-30

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 NCT01501656 on ClinicalTrials.gov