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Liquid Biopsy-Based Pre-Screening to Streamline LDCT Lung Cancer Screening in High-Risk Individuals

ConditionsLung CancerLung NeoplasmsEarly Lung Cancer DetectionCancer ScreeningHigh-Risk Populations
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-75
SponsorNational University Hospital, Singapore

About this trial

This study evaluates the feasibility and cost-effectiveness of using a blood-based liquid biopsy assay as a pre-screening tool before low-dose CT (LDCT) for lung cancer screening. By identifying individuals unlikely to have lung cancer, this approach aims to reduce unnecessary LDCT scans, radiation exposure, and healthcare costs, while improving early detection, particularly among high-risk individuals including never-smokers with a family history of lung cancer.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

No prior history of lung cancer

Current or former smoker (quit within the past 15 years), aged 55-74 years, with a smoking history of ≥30 pack-years; OR

Never-smoker aged 55-75 years with a first-degree family history of lung cancer

Able and willing to provide written informed consent

Disqualifiers

Pregnant or breastfeeding women

Inability or unwillingness to comply with study procedures

Known allergy or contraindication to CT contrast agents

Prior low-dose CT (LDCT), CT thorax, or PET-CT performed within 12 months prior to enrollment

Trial design

Design model

Sequential

Treatments tested in this trial

  • Liquid Biopsy (SPOT-MAS Assay)

    Diagnostic test

    Blood-based genome-wide DNA methylation assay performed on plasma samples to detect tumor-associated methylation patterns suggestive of lung cancer.

  • Exosome-Based Liquid Biopsy Assay

    Diagnostic test

    Blood-based assay analyzing exosome-associated biomarkers to support early detection of lung cancer.

  • Low-Dose CT Thorax (LDCT)

    Diagnostic test

    Low-dose computed tomography of the thorax performed for lung cancer screening

Treatment groups

140 Participants
are divided into 3 treatment groups
Group A: High-Risk Individuals Without Known Lung CancerExperimental treatment 3 interventions
Group B: Early-Stage Lung Cancer Patients (Stage I-II)Experimental treatment 2 interventions
Group C: Advanced-Stage Lung Cancer Patients (Stage III-IV)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Negative Predictive Value of Liquid Biopsy Pre-Screening

Description: Negative predictive value of the liquid biopsy assay (SPOT-MAS), defined as the proportion of participants with a negative liquid biopsy result who have no lung cancer detected by low-dose computed tomography (LDCT) and clinical follow-up. Unit of Measure: Proportion (%)

Time frame
12 months
2

Reduction in Unnecessary LDCT Screening

Proportion of high-risk participants who receive a negative liquid biopsy (SPOTMAS) result, representing individuals who may be eligible to defer LDCT screening under a liquid biopsy-guided pre-screening strategy. Unit of Measure: Proportion (%)

Time frame
12 months

Secondary outcomes

1

Diagnostic Accuracy of Liquid Biopsy Assays

Sensitivity, specificity and positive predictive value of liquid biopsy assays (SPOT-MAS and exosome-based assays) compared with LDCT and clinical follow-up. Unit of Measure: Proportion (%)

Time frame
12 months
2

Cost-Effectiveness of Liquid Biopsy Pre-Screening

Comparative cost analysis (Mean total screening-related cost) of liquid biopsy-guided screening versus LDCT-only screening. Unit of Measure: Cost (USD per participant)

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National University Hospital, Singapore

Lead sponsor

Gene Solutions

Collaborator

Source ClinicalTrials.gov
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