Epigenetic Testing for Breast Cancer Risk Stratification

NCT01501656 | Completed DMC

• 2 other identifiers: STU 092011-047BC103910
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• DNA methylation

  This objective assesses methylation of seven genes in 97 archival breast cancer samples.

  2 years

Secondary Outcomes (1)

• Frequency of methylation

  2 years

Eligibility Criteria

• Age: 30 Years - 79 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• \<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
• Inherited coagulation disorder
• Current coumadin use

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• United States Department of Defense: collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75204, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

benign samples from unselected healthy control populations

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Rolf Brekken, MD

  UT Southwetstern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2011
• First Posted: December 29, 2011
• Study Start: May 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: June 1, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)