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Liquid Biopsy-Based Pre-Screening to Streamline LDCT Lung Cancer Screening in High-Risk Individuals

NCT07358715 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-01-22

No results posted yet for this study

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.

Conditions

  • Lung Cancer
  • Lung Neoplasms
  • Early Lung Cancer Detection
  • Cancer Screening
  • High-Risk Populations

Interventions

DIAGNOSTIC_TEST

Liquid Biopsy (SPOT-MAS Assay)

Blood-based genome-wide DNA methylation assay performed on plasma samples to detect tumor-associated methylation patterns suggestive of lung cancer.

DIAGNOSTIC_TEST

Exosome-Based Liquid Biopsy Assay

Blood-based assay analyzing exosome-associated biomarkers to support early detection of lung cancer.

DIAGNOSTIC_TEST

Low-Dose CT Thorax (LDCT)

Low-dose computed tomography of the thorax performed for lung cancer screening

Sponsors & Collaborators

  • Gene Solutions

    collaborator INDUSTRY

  • National University Hospital, Singapore

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07358715 on ClinicalTrials.gov