NCT05462795

Liquid Biopsy for Early Non-small Lung Cancer Detection

Liquid Biopsy to Distinguish Malignant From Benign Pulmonary Nodules and to Monitor Response to Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 171 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This clinical trial will assess the performance of a liquid biopsy assay to identify cancer in indeterminant pulmonary nodules identified by CT screening of high-risk individuals and evaluate the capability of the liquid biopsy assay to monitor response to surgical resection.

Detailed description

This clinical study examines the feasibility of a liquid biopsy methylation assay to detect non-small lung cancer. First, the investigators will apply their liquid biopsy assay to screen for lung cancer in indeterminate pulmonary nodules suspicious for cancer. Second, the investigators will assess the utility of liquid biopsy to assess tumor dynamics after surgical resection with curative intent. Third, the investigators will assess the presence or absence of this methylation assay in healthy normal persons without a history of lung cancer.

Conditions

• Non Small-cell Lung Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Liquid biopsy for aberrant DNA methylation analysis - Indeterminate pulmonary nodule	10 cc of blood is collected at one time point, which is prior to biopsy procedure
DIAGNOSTIC_TEST	Liquid biopsy for aberrant DNA methylation analysis - Known lung cancer for surgical resection	10 cc of blood is collected at three time points: 1) before surgery; 2) 4-6 weeks post surgery; and 3) 6 months post surgery
DIAGNOSTIC_TEST	Liquid biopsy for aberrant DNA methylation analysis - Healthy volunteer	10 cc of blood is collected at one time point
DIAGNOSTIC_TEST	Liquid biopsy for aberrant DNA methylation analysis - Benign lung disease	30 cc of blood is collected at one time point

Timeline

• Start date: 2022-08-02
• Primary completion: 2024-03-22
• Completion: 2024-03-22
• First posted: 2022-07-18
• Last updated: 2024-12-16

Locations

1 site across 1 country: United States