Lung Cancer Clinical Trial
Fluid Biopsy for the Diagnosis of Lung Cancer
Summary
This trial collects and studies blood samples via fluid biopsy for the diagnosis of lung cancer. Studying blood samples in the laboratory may help doctors develop a blood test for lung cancer in the future and provide a better way to screen patients for lung cancer.
Full Description
PRIMARY OBJECTIVE:
I. To estimate the sensitivity and specificity of the fluid biopsy in establishing a diagnosis of bronchogenic carcinoma.
SECONDARY OBJECTIVES:
I. To determine the accuracy of determination of the histologic subtype of bronchogenic lung cancer.
II. To determine the relative contribution of cell based high definition circulating tumor cell assay (HD-CTC) and imaging mass cytometry (IMC) and plasma based circulating tumor deoxyribonucleic acid (ctDNA) assays in determination of diagnosis and histologic subtype.
OUTLINE:
Patients undergo collection of blood samples on day 1 for analysis via high definition (HD)-single cell analysis (SCA) fluid biopsy. Medical charts of patients are reviewed at 3 months post-biopsy or computed tomography (CT) screening.
After completion of study, patients are followed for up to 1 year.
Eligibility Criteria
Inclusion Criteria:
Scheduled to undergo a diagnostic biopsy for possible lung cancer or
Completed a diagnostic lung cancer biopsy in the prior 2 weeks and has not yet undergone treatment or
Planning or completed in the last 2 weeks a CT lung cancer screen
Ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
Known other solid tumor malignancy other than lung cancer requiring ongoing active treatment
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