Liquid Biopsy-Based Pre-Screening to Streamline LDCT Lung Cancer Screening in High-Risk Individuals
Recruiting · NCT07358715 · Interventional (participants receive a specific treatment) · Lead sponsor: National University Hospital, Singapore
View the official record on ClinicalTrials.gov →Interventions studied
Exosome-Based Liquid Biopsy AssayLiquid Biopsy (SPOT-MAS Assay)Low-Dose CT Thorax (LDCT)
What this trial is about
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.
Who can take part
Age range
21 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- National University Hospital Singapore - Singapore, Singapore