Liquid biopsy pre-screen to reduce unnecessary low-dose CT for high-risk lung cancer
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 21 Years to 75 Years |
| Sex | All |
| Sponsor | National University Hospital, Singapore Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Singapore) |
| Trial ID | NCT07358715 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Singapore
- National University Hospital Singapore — Singapore, Singapore (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.