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Validation of the SPOT-MAS Lung Test Using Circulating Tumor DNA for the Detection of Lung Cancer
Sponsor: Gene Solutions
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
Conditions
Locations (1)
Medical Genetics Institute
Ho Chi Minh City, Vietnam