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ACTIVE NOT RECRUITING
NCT03147430

Early Detection of Breast Cancer in Women With Suspicious Mammograms

Sponsor: Sentara Norfolk General Hospital

View on ClinicalTrials.gov

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

OTHER

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