Validation of the SPOT-MAS Lung Test Using Circulating Tumor DNA for the Detection of Lung Cancer

This is an observational clinical trial, aiming to evaluate the efficacy of the SPOTMAS LUNG (SML) test compared to Low dose CTScan (LDCT)/None contrast CTScan (NCCT) in two distinct risk populations: * Cohort A: To demonstrate that SML is concordant with LDCT/NCCT in general population lung cancer screening, including low-risk (LRs0-1-2), intermediate-risk (LRs3), and high-risk (LRs4) groups. * Cohort B: To validate the sensitivity and specificity of SML in the high-risk group (LRs4).

NCT Number	NCT07126626
Lead Sponsor	Gene Solutions
Conditions	Lung Diseases, Lung Cancer Screening
Enrollment	1,184 participants
Start Date	2025-08-18
Primary Completion	2027-07-31 (estimated)
Study Completion	2027-07-31 (estimated)
Updated on ClinicalTrials.gov	2025-08-17