Overview
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.
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
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