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

NCT07126626 | Not Yet Recruiting

• 1 other identifier: LUNGCARE
• Study Type: observational
• Target: 1,184
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

SPOT-MAS Lung Test

Outcome Measures

Primary Outcomes (1)

• The overall objective of this study is to assess the performance of SPOT-MAS LUNG (SML) in two different scenarios: lung cancer screening (Cohort A) and lung cancer diagnosis (Cohort B).

  Cohort A • Characteristics: Screening population, including low-risk (LRs0-1-2), intermediate-risk (LRs3), and high-risk (LRs4) patients, taken 10mL blood for SML test. Cohort B • Characteristics: High-risk patients (LRs 4), taken 10mL blood for SML test.

  24 months

Secondary Outcomes (1)

• Cohort A: To demonstrate that SML is concordant with LDCT/NCCT in the screening population. Cohort B: To assess the specificity and sensitivity of SML in detecting LC in patients with LRs4.

  24 months

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cohort A: Patients visit the hospital and are screened according to inclusion/exclusion criteria and are indicated for routine LDCT or NCCT (Enrollment Date D1, results unknown). Cohort B: Patients visit the hospital and are screened according to inclusion/exclusion criteria and have LDCT or NCCT or CECT results of Lung-RADS 4, valid within 30 days up to the study enrollment date.

You may qualify if:

• Cohort A
• Volunteers (participants) aged 50-80 years at the time of consent.
• % smokers with a smoking history of 20 pack-years who currently smoke or have quit within the past 15 years.
• % never-smokers or light smokers (\< 20 pack-years or quit \> 15 years) who are first- or second-degree relatives of LC patients.
• Willing to undergo LDCT/NCCT of the chest for lung cancer screening.
• Willing to consent to an investigational blood draw during the index LDCT/NCCT screening visit and before any invasive procedures or treatment for lung cancer diagnosis.
• Willing to consent to a 1-year follow-up and additional follow-ups as per protocol.
• Cohort B
• Subjects aged 50-80 years at the time of consent.
• % smokers with a smoking history of 20 pack-years who currently smoke or have quit within the past 15 years.
• % never-smokers or light smokers (\< 20 pack-years or quit \> 15 years) who are first- or second-degree relatives of LC patients.
• Have undergone LDCT/NCCT of the chest for lung cancer screening/diagnosis, including only high-risk lesions (LUNG-RADS 4).
• Willing to consent to an investigational blood draw before any invasive procedures (CECT/PET-CT/biopsy) or treatment for lung cancer diagnosis.
• Willing to consent to a 1-year follow-up and additional follow-ups as per protocol.

You may not qualify if:

• Subject has a health problem that substantially limits life expectancy and/or the ability or willingness to have curative lung surgery.
• Subject is undergoing CECT for investigation of highly suspicious symptoms for lung cancer.
• Pre-existing or history of lung cancer.
• History of any malignancy (subjects who have undergone surgical removal of skin squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of provision of informed consent for the study).
• Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs.
• Currently receiving treatment for pneumonia.
• Any major physical trauma (e.g., disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent.
• Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
• Participation in a clinical research study in which an experimental medication and/or medical procedure has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of subject screening.

Sponsors & Collaborators

• Gene Solutions: lead

Study Sites (1)

Medical Genetics Institute

Ho Chi Minh City, Vietnam

Location

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Biospecimen

Retention: SAMPLES WITH DNA

Cohort A 10mL blood sample is collected from eligible participants who have lung cancer screening and are indicated for routine LDCT or NCCT at the enrollment date, for the SPOT-MAS LUNG (SML) test. The blood sample will be transported to the central laboratory of the Institute of Medical Genetics (IMG) Cohort B: 10mL blood sample is collected from eligible participants, who have LDCT or NCCT or CECT results of Lung-RADS 4, valid within 30 days counted from the enrollment date, for the SPOT-MAS LUNG (SML) test. The blood sample will be transported to the central laboratory of the Institute of Medical Genetics (IMG) for plasma separation. The separated plasma will be stored frozen (-80°C) until used for cfDNA extraction and subsequent analytical steps of the SML test procedure.

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Central Study Contacts

Sinh Nguyen D, PhD. MD

CONTACT

+84834105425; sinhnguyen@genesolutions.vn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: August 17, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

VN (1)