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

ConditionsLung Diseases Lung Cancer Screening

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

This trial does not accept healthy volunteers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

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.

Time frame

24 months

Secondary outcomes

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.

Cohort A: The objective of the study is to demonstrate that SML and LDCT have a high level of agreement, with a Cohen's Kappa coefficient greater than 0.81. * Endpoint: The level of agreement between SML and LDCT/NCCT. Cohort B: In a previous case-control study, SML demonstrated a specificity of 92% and a sensitivity of 90% \[9\]. Thus, this study will be considered successful if the lower-bound of the two-sided 95% Wilson CI of SM for LC sensitivity exceeds 80% and the lower-bound of the two-sided 95% Wilson CI of SM for LC specificity exceeds 82%. * Endpoint: Specificity and sensitivity of SML.

Time frame

24 months

Sponsors and contacts

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Gene Solutions

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: