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Title Automated Systems for Detection and Molecular Characterization of Circulating Tumor Cells

IRB ADL 1112

CC 12-475

Hospital Main Campus

Phase N/A

Disease Breast



  1. Primary
    • Determine the clinical performance of CTCscope and compare it with the FDA-approved CellSearch system
    • Molecular phenotyping of CTCs for targeted therapy
Inclusion Criteria

Inclusion Criteria

  1. The principle inclusion criteria are progressive, measurable metastatic breast cancer with their primary tumor HER2 status known. Prior adjuvant therapy, treatment of metastatic disease, or both are all permitted. We will be focusing on clinical validation of the automated CTCscope system, not proving its clinical utility that would require substantially more resources and longer time frame beyond the scope of this proposal.
  2. The age range is expected to be that of the natural age related incidence of breast cancer. The mean age of participants accrued in the current study is assumed to be approximately 55 with a range 31 to 79.
  3. The mental and physical health status will be such that patients would be able to understand and approve informed consent. Patients must consent to be in the study and must have signed an approved consent form that conforms to federal and institutional guidelines.
  4. Patient must have radiologic or histologic evidence of metastatic breast cancer.
  5. Hemoglobin > 8.5 gm percent
  6. Hematocrit > 25.5 percent
  7. Prior Treatment: No limitations. No medications will exclude patients from this study.
Exclusion Criteria

Exclusion Criteria

Exclusion Criteria Not Available