NCT04162678

Fluid Biopsy for the Diagnosis of Lung Cancer

Establishing a Diagnosis of Lung Cancer Through a Fluid Biopsy

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 51 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of blood via HD-SCA fluid biopsy
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Liquid Biopsy	Undergo collection of blood via HD-SCA fluid biopsy
OTHER	Medical Chart Review	Review of medical chart

Timeline

• Start date: 2020-01-13
• Primary completion: 2024-12-05
• Completion: 2024-12-09
• First posted: 2019-11-14
• Last updated: 2025-09-05

Locations

2 sites across 1 country: United States