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Early Detection of Breast Cancer in Women With Suspicious Mammograms
Sponsor: Sentara Norfolk General Hospital
Summary
This is a non-treatment study. It will not involve the use of any investigational drug or device. Potential participants will be enrolled through direct contact with collaborating clinical sites when the patient's annual 3D mammogram report yields a BIRADS rating of 4-5. The clinical Investigators or a member of their staff will conduct consent discussion once a suspicious mammogram report is identified or if a patient is referred for imaging of a suspicious area in the breast. After consenting the participant will be asked to donate a blood sample, a saliva sample, medical records pertaining to the suspicious mammogram report and a medical history questionnaire. The participants will be followed after one year to capture progression or resolution of their suspicious mammogram report. After a biopsy confirms the diagnosis of cancer or benign lesion, a recut sample of the tissue may be requested for research.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
270
Start Date
2017-05-08
Completion Date
2025-12-31
Last Updated
2025-06-06
Healthy Volunteers
No
Conditions
Interventions
Biomarkers
Experimentally discover putative plasma markers for detecting early, stage I breast cancer in the setting of a suspicious mammogram and distinguish those cancers from benign lesions b) verify the putative markers through molecular profiling; and c) validate the markers by mass spectrometry.
Locations (2)
Dorothy G Hoefer Comprehensive Breast Center
Newport News, Virginia, United States
Sentara Norfolk General Breast Center
Norfolk, Virginia, United States