Epigenetic Testing for Breast Cancer Risk Stratification

This study is not yet open for participant recruitment.
Verified September 2011 by University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
First received: December 27, 2011
Last updated: December 28, 2011
Last verified: September 2011

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.

Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epigenetic Testing for Breast Cancer Risk Stratification

Resource links provided by NLM:

Further study details as provided by University of Texas Southwestern Medical Center:

Biospecimen Retention:   Samples With DNA

benign samples from unselected healthy control populations

Estimated Enrollment: 429
Study Start Date: January 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   30 Years to 79 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Archived tumor tissue, Newly diagnosed primary breast cancer patients and healthy women who have never been diagnosed with breast cancer


Inclusion Criteria:

  • Women between the ages of 30 and 79.
  • Untreated stage 1 - 3 invasive breast cancer or a woman never diagnosed with breast cancer.
  • BI-RADS 1, 2, or 3 breast imaging within 12 months for women >40 years of age recruited into the control group.

Exclusion Criteria:

  • <30 or >80 years of age
  • Unable to provide informed consent
  • Presence of an undefined palpable or mammographic breast lesion suspicious for malignancy (BIRADS 4 or 5)
  • Breast implants
  • Bilateral prophylactic mastectomy
  • Any prior breasts irradiation
  • Any systemic chemotherapy in the past
  • Performance status that restricted normal activity for a significant portion of the day
  • Use of luteinizing-hormone-releasing-hormone (LHRH) analogs, prolactin inhibitors, antiandrogens, or systemic glucocorticoids within three months
  • Ever use of tamoxifen, raloxifene, or other SERMs
  • Ever use of aromatase inhibitors
  • Pregnancy or lactation within six months
  • Bleeding diathesis of any kind

    1. Inherited coagulation disorder
    2. Current coumadin use
    3. Use of drugs that inhibit platelet aggregation within 10 days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01501656

Contact: Linda Flores, BA 214-648-7042 linda.flores@utsouthwestern.edu
Contact: Vanessa Tagoe, MA 214-648-7020 vanessa.tagoe@utsouthwestern.edu

United States, Texas
UT Southwestern Medical Center Not yet recruiting
Dallas, Texas, United States, 75204
Principal Investigator: David Euhus, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Principal Investigator: David Euhus, MD UT Southwetsren Medical Center
  More Information

No publications provided

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01501656     History of Changes
Other Study ID Numbers: STU 092011-047, BC103910
Study First Received: December 27, 2011
Last Updated: December 28, 2011
Health Authority: United States: Army Medical Research and Materiel Command (USAMRMC)
United States: Office of Research Protections (ORP)
United States: Human Research Protection Office (HRPO)
United States: UT Southwestern Institutional Review Board (IRB)

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

ClinicalTrials.gov processed this record on April 14, 2014