Clinical Trial 19209

• Overview

  Study Title:

  Combined Imaging and Blood Biomarkers for Breast Cancer Diagnosis

  Summary:

  In this study, investigators are analyzing computer measurements from mammograms and combining them with measurements from blood samples to make improved diagnostic decisions. The goal is to eliminate biopsy procedures when they are not required for some women.

  Objective:

  The primary objectives of this project are to: (1) construct a combined repository with mammographic images and biospecimens as an EDRN resource; and (2) perform preliminary analyses to evaluate the possibility that blood analytes combined with automated image measurements can provide adequate performance to eliminate a portion of the negative biopsies while maintaining high sensitivity in a breast screening population restricted to those women designated as a BI-RADS 4.

• Inclusion Criteria

  • History of ductal carcinoma in situ (DCIS) (>1 year post-diagnosis)
  • History of atypical ductal hyperplasia (ADH)
  • History of Benign Biopsies
  • Cyst Aspiration
  • Complicated Cyst (for pathology)

• Exclusion Criteria

  • Males
  • > History of invasive breast or other cancer excluding basal/squamous cell skin cancer
  • Already diagnosed for the current breast presentation (cancer or otherwise)
  • Renal Disease and/or Transplant/non cancer
  • Lung Disease and/or Transplant/non cancer
  • Heart Disease and/or Transplant/non cancer

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