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

NCT07126626 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1184

Last updated 2025-08-17

No results posted yet for this study

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).

Conditions

  • Lung Diseases
  • Lung Cancer Screening

Sponsors & Collaborators

  • Gene Solutions

    lead INDUSTRY

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-18
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07126626 on ClinicalTrials.gov