Liquid Biopsy-Based Pre-Screening to Streamline LDCT Lung Cancer Screening in High-Risk Individuals
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
National University Hospital, Singapore
140 participants
Nov 1, 2024
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria16
- 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 Criteria8
- 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
Interventions
Blood-based genome-wide DNA methylation assay performed on plasma samples to detect tumor-associated methylation patterns suggestive of lung cancer.
Blood-based assay analyzing exosome-associated biomarkers to support early detection of lung cancer.
Low-dose computed tomography of the thorax performed for lung cancer screening
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07358715