MedTrace Logo

Early Detection of Breast Cancer in Women With Suspicious Mammograms

NCT03147430 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 270

Last updated 2025-06-06

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Dorothy G. Hoefer Foundation

    collaborator OTHER

  • George Mason University

    collaborator OTHER

  • Sentara Norfolk General Hospital

    lead OTHER

Principal Investigators

  • Richard Hoefer, DO · Sentara Healthcare

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-08
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03147430 on ClinicalTrials.gov