Liquid biopsy pre-screen to reduce unnecessary low-dose CT for high-risk lung cancer
Official title: A Multimodal Liquid Biopsy-Based Assay as a Pre-Screening Test Before Low Dose CT Thorax (LDCT) to Streamline Lung Cancer Screening in High-Risk Individuals
Run by National University Hospital, Singapore · NCT07358715 · Data updated 2026-11-12
This will test a blood-based liquid biopsy to see if it can identify high-risk people who can safely skip or delay a low-dose CT scan for lung cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years to 75 Years |
| Sex | All |
| Enrollment | 140 (estimated) |
| Sponsor | National University Hospital, Singapore Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Singapore) |
| Status | Recruiting |
| Started | November 1, 2024 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | January 22, 2026 |
| Trial ID | NCT07358715 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are high-risk adults (roughly 55–75 years) who are current or former heavy smokers or never-smokers with a first-degree family history of lung cancer, as well as treatment‑naïve patients with newly diagnosed stage I–IV lung cancer for the comparison cohorts.
✕Probably not a fit
People with a prior history of treated lung cancer, those already receiving lung cancer therapy, pregnant individuals, or anyone unwilling to have blood draws or attend LDCT visits are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective interventional study uses multimodal blood-based liquid biopsy assays (DNA methylation and exosome biomarkers, including the SPOT-MAS assay) as a pre-screen before low-dose CT (LDCT) in high-risk individuals. The protocol enrolls three cohorts: healthy high-risk participants, treatment-naïve early-stage lung cancer patients, and treatment-naïve advanced-stage lung cancer patients for comparison. Participants provide blood samples for the liquid biopsy and undergo LDCT to compare test performance and downstream imaging use. The study will also model potential cost-effectiveness and reductions in unnecessary LDCT scans and radiation exposure.
Why it matters
Potential benefit: If successful, this approach could reduce unnecessary LDCT scans, lower radiation exposure and healthcare costs, and improve early detection among high-risk individuals.
How similar studies have gone: Prior work on DNA methylation and other liquid biopsy methods has shown promising signals for early lung cancer detection, but using multimodal liquid assays specifically as an LDCT pre-screen is relatively novel and not yet widely validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria High-Risk Individuals (n = 100) * No prior history of lung cancer * Meets one of the following high-risk definitions: * 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 Early-Stage Lung Cancer Patients (n = 20) * Aged ≥21 years * Histologically or clinically confirmed stage I-II lung cancer * Treatment-naïve (no prior surgery, chemotherapy, radiotherapy, or immunotherapy for lung cancer) * Able and willing to provide written informed consent Advanced-Stage Lung Cancer Patients (n = 20) * Aged ≥21 years * Histologically or clinically confirmed stage III-IV lung cancer * Treatment-naïve (no prior systemic or local therapy for lung cancer) * Able and willing to provide written informed consent Exclusion Criteria Applicable to All Participants * Pregnant or breastfeeding women * Inability or unwillingness to comply with study procedures High-Risk Individuals Only * 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 Lung Cancer Cohorts Only • Receipt of any prior cancer-directed treatment for lung cancer
Where it's running
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National University Hospital Singapore
Singapore, Singapore Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.