Validation of the SPOT-MAS Lung Test Using Circulating Tumor DNA for the Detection of Lung Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-80
SponsorGene Solutions
About this trial
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).
Eligibility criteria
Qualifiers
Volunteers (participants) aged 50-80 years at the time of consent.
50% smokers with a smoking history of 20 pack-years who currently smoke or have quit within the past 15 years.
50% 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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Source ClinicalTrials.gov