Blood Test for Early Diagnosis of Breast Cancer and Patients with Pulmonary (Lung) Lesions

Study ID
STU 112015-070

Study Sites

  • Clements University Hospital

James Wright

Principal Investigator
Nisha Unni, M.D.


improve the sensitivity of the assay for detection of circulating tumor cells with the objective of detecting breast cancer before metastases have occurred.

Participant Eligibility

1. All patients 18 years of age and older.
2. Cohort 1 only: The initial phase of the study will include 15 patients with metastatic breast cancer with measurable disease at any stage of treatment.
Cohort 2 only: The next phase of the trial will include patients with early breast cancer or pulmonary lesions (T1 or T2) as previously described and no known prior history or malignancy. This will be the main study population.
Cohort 3 only: The control population will be patients who had similar screening procedures but not found to have lesions but further workup revealed a benign lesion including LCIS, etc.