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Multimodal Liquid Biopsy Assay as a Pre-Screening Test Before Low Dose CT Thorax to Improve Lung Cancer Screening in High-Risk Individuals
Led by National University Hospital, Singapore · Updated on 2026-01-22
140
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
N
National University Hospital, Singapore
Lead Sponsor
G
Gene Solutions
Collaborating Sponsor
AI-Summary
What this Trial Is About
Lung cancer is a leading cause of cancer deaths, often diagnosed late. This research investigates a blood-based liquid biopsy test used before low-dose CT (LDCT) scans to identify high-risk individuals unlikely to have lung cancer. The goal is to reduce unnecessary LDCT scans, radiation exposure, and healthcare costs, while improving early detection, especially for high-risk groups including never-smokers with a family history of lung cancer. The study involves three groups: high-risk individuals without lung cancer, patients with early-stage lung cancer, and patients with advanced-stage lung cancer. High-risk participants receive two blood tests: a DNA methylation-based assay (SPOT-MAS) and an exosome-based assay, followed by an LDCT scan. If the blood test is positive but LDCT is negative, a CT-PET scan is offered. Early and advanced lung cancer patients provide blood samples for assay evaluation. Some participants may have additional follow-up tests depending on results. Participants will undergo blood collection, LDCT scans, and possibly CT-PET or other imaging tests. Researchers will measure how well the liquid biopsy tests predict lung cancer absence, the number of people who might avoid LDCT scans, and test accuracy compared to imaging. Cost-effectiveness and safety will also be assessed. The study lasts up to 12 months, monitoring participants closely throughout.
CONDITIONS
Brief Title
Liquid Biopsy-Based Pre-Screening to Streamline LDCT Lung Cancer Screening in High-Risk Individuals
Who Can Participate
Eligibility Criteria
You may qualify if you...
- High-risk individuals with no prior history of lung cancer
- Current or former smokers aged 55 to 74 years with a smoking history of at least 30 pack-years, or never-smokers aged 55 to 75 years with a first-degree family history of lung cancer
- Aged 21 years or older
- Histologically or clinically confirmed stage I-II lung cancer patients who are treatment-naive
- Histologically or clinically confirmed stage III-IV lung cancer patients who are treatment-naive
- Able and willing to provide written informed consent
You will not qualify if you...
- Pregnant or breastfeeding women
- Unable or unwilling to comply with study procedures
- Known allergy or contraindication to CT contrast agents (high-risk individuals only)
- Prior low-dose CT, CT thorax, or PET-CT performed within 12 months before enrollment (high-risk individuals only)
- Receipt of any prior cancer-directed treatment for lung cancer (lung cancer cohorts only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for blood collection and initial assessments
Duration - Up to 3 months following initial blood collection
Participants undergo blood collection for two liquid biopsy assays and low-dose CT thorax screening to detect lung cancer presence.
1 to 3 visits including blood collection, LDCT screening, and potential CT-PET scan if indicated
Duration - Up to 6 months for repeat blood draw if needed, plus additional monitoring as per physician discretion
Participants with positive or inconclusive liquid biopsy results receive follow-up assessments and additional diagnostic tests as needed, including possible repeat blood collection.
1 to 2 visits depending on test results and follow-up requirements
Duration - Single timepoint during study participation
Participants diagnosed with early or advanced-stage lung cancer undergo blood collection for liquid biopsy testing to evaluate assay performance across disease stages.
1 visit (in-person) for blood collection
Trial Site Locations
Total: 1 location
1
National University Hospital Singapore
Singapore, Singapore, 119228
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
SCREENING
Number of Arms
3
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