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NOT YET RECRUITING
NCT07126626

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

Sponsor: Gene Solutions

View on ClinicalTrials.gov

Summary

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).

Official title: Multi-center Prospective Validation of the SPOT-MAS Lung Test Using Circulating Tumor DNA for the Detection of Lung Cancer

Key Details

Gender

All

Age Range

50 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

1184

Start Date

2025-08-18

Completion Date

2027-07-31

Last Updated

2025-08-17

Healthy Volunteers

No

Locations (1)

Medical Genetics Institute

Ho Chi Minh City, Vietnam