Liquid Biopsy-Based Pre-Screening to Streamline LDCT Lung Cancer Screening in High-Risk Individuals
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
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
Treatments tested in this trial
- Liquid Biopsy (SPOT-MAS Assay)
- Exosome-Based Liquid Biopsy Assay
- Low-Dose CT Thorax (LDCT)
Treatment groups
140 Participants
are divided into 3 treatment groupsLocations
1National University Hospital Singapore119228, Singapore Singapore
Sponsors and collaborators
National University Hospital, Singapore
Lead sponsor
Gene Solutions
Collaborator
Source ClinicalTrials.gov