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Brief Title: Fluid Biopsy for the Diagnosis of Lung Cancer
Official Title: Establishing a Diagnosis of Lung Cancer Through a Fluid Biopsy
Study ID: NCT04162678
Brief 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.
Detailed 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Los Angeles County-USC Medical Center, Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
Name: Jorge J Nieva, MD
Affiliation: University of Southern California
Role: PRINCIPAL_INVESTIGATOR