Status:
COMPLETED
Epigenetic Testing for Breast Cancer Risk Stratification
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
United States Department of Defense
Conditions:
Breast Cancer
Eligibility:
FEMALE
30-79 years
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 adja...
Detailed Description
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 adja...
Eligibility Criteria
Inclusion
- 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
- \<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
- Use of drugs that inhibit platelet aggregation within 10 days
Key Trial Info
Start Date :
May 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT01501656
Start Date
May 1 2012
End Date
November 1 2014
Last Update
June 1 2016
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75204