NCT07126626

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,184 (estimated)
• Sponsor: Gene Solutions · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a prospective, multi-center cohort study to access the performance of SPOT-MAS Lung (SML) in two different scenarios: lung cancer screening (Cohort A) and lung cancer diagnosis (Cohort B). Sample size and accuracy analyses were performed independently for the study objectives within each cohort. The minimum sample size for Cohort A is approximately 526 samples. Participants will be randomly selected from the screening population for this study without prior LDCT classification criteria. The minimum sample size for Cohort B is approximately 658 samples. Participants will be selected from individuals who have undergone LDCT/NCCT with LUNG-RADS 4 results. Each Cohort A or B requires a 50% proportion of smokers and 50% of never-smokers or light-smokers, 10mL blood sample and LDCT/NCCT are collected. Cohort A: According to current lung cancer screening and diagnosis guidelines, volunteers will undergo the following imaging methods: Lung-RADS 3: Recommended to have a repeat LDCT after 6 and 12 months. Lung-RADS 0-1-2: Recommended to have a repeat LDCT after 12 months. Lung-RADS 4: Recommended to have contrast-enhanced computed tomography (CECT). Cohort B: According to current lung cancer screening and diagnosis guidelines, the Lung-RADS 4 group will be recommended for contrast-enhanced computed tomography (CECT). Cohort A and B: If CECT results show a lesion ≥8mm in the lung, biopsy is recommended, and histopathological results evaluated. * If histopathology is malignant/confirms cancer: proceed with treatment. Treatment costs ARE NOT covered by the study. * If histopathology is benign: repeat LDCT after 12 months. If CECT results show a lesion \<8mm in the lung, or no lesion is seen in the lung, repeat LDCT after 12 months. LDCT or CECT fee in Month 6 and Month 12 will be covered by this study.

Conditions

• Lung Diseases
• Lung Cancer Screening

Timeline

• Start date: 2025-08-18
• Primary completion: 2027-07-31
• Completion: 2027-07-31
• First posted: 2025-08-17
• Last updated: 2025-08-17

Locations

1 site across 1 country: Vietnam