NCT05384769

Feasibility of Cell-Free DNA Liquid Biopsy in Screening High-Risk Patients for Lung Cancer

Feasibility Study of Lung Cancer Screening Using Cell-Free DNA Liquid Biopsy at Home in High-Risk Current and Former Smokers

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This clinical trial investigates how practical and doable (feasibility) cell-free deoxyribonucleic acid (DNA) liquid biopsy is in screening high-risk patients for lung cancer. Currently, a low dose computed tomography (CT) scan is used to screen for lung cancer, however, due to various factors, few high-risk patients are screened. Liquid biopsy utilizes technology that can detect small amounts of DNA shed by cancer cells and may be able to spot lung cancer at an earlier stage. If a positive result comes back from the liquid biopsy, a patient may be more willing to get a low dose CT (LDCT) scan, possibly confirming the biopsy's findings and thus leading to more early lung cancer detection.

Detailed description

PRIMARY OBJECTIVE: I. To determine the feasibility of lung cancer screening using liquid biopsy in a community setting. SECONDARY OBJECTIVES: I. To determine screening follow-through rates in those who agreed to undergo screening by preferred modality (liquid biopsy versus \[vs\] LDCT). II. To determine the rate of LDCT following liquid biopsy (in those who underwent liquid biopsy) after stratifying by test result (negative versus positive). III. To compare participant sociodemographic factors (age, sex, race/ethnicity, educational background) and survey scores across screening preference (liquid biopsy vs. LDCT). OUTLINE: Participants choose 1 of 2 cohorts. COHORT A: Participants undergo collection of blood sample (liquid biopsy), with option to undergo LDCT if liquid biopsy results are positive. COHORT B: Participants undergo low dose CT with optional liquid biopsy on the same day as LDCT. After completion of study, patients are followed up at 6 months.

Conditions

• Lung Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Liquid Biopsy	Undergo liquid biopsy
PROCEDURE	Low Dose Computed Tomography of the Chest	Undergo low dose CT
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2022-07-29
• Primary completion: 2029-01-28
• Completion: 2029-01-28
• First posted: 2022-05-20
• Last updated: 2025-10-07

Locations

1 site across 1 country: United States