NCT07358715

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
33mo left

Started Nov 2024

Typical duration for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Nov 2024Dec 2028

Study Start

First participant enrolled

November 1, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

3.2 years

First QC Date

January 6, 2026

Last Update Submit

January 13, 2026

Conditions

Lung CancerLung NeoplasmsCancer ScreeningEarly Lung Cancer DetectionHigh-Risk Populations

Keywords

Liquid biopsyDNA methylationExosomesBlood-based screeningLow-dose CTLDCTLung cancer screeningEarly cancer detectionHigh-risk individualsNever-smokersMultimodal assay

Outcome Measures

Primary Outcomes (2)

  • Negative Predictive Value of Liquid Biopsy Pre-Screening

    Description: Negative predictive value of the liquid biopsy assay (SPOT-MAS), defined as the proportion of participants with a negative liquid biopsy result who have no lung cancer detected by low-dose computed tomography (LDCT) and clinical follow-up. Unit of Measure: Proportion (%)

    12 months

  • Reduction in Unnecessary LDCT Screening

    Proportion of high-risk participants who receive a negative liquid biopsy (SPOTMAS) result, representing individuals who may be eligible to defer LDCT screening under a liquid biopsy-guided pre-screening strategy. Unit of Measure: Proportion (%)

    12 months

Secondary Outcomes (2)

  • Diagnostic Accuracy of Liquid Biopsy Assays

    12 months

  • Cost-Effectiveness of Liquid Biopsy Pre-Screening

    12 months

Study Arms (3)

High-Risk Individuals Without Known Lung Cancer

EXPERIMENTAL

High-risk individuals without a prior diagnosis of lung cancer undergo blood-based liquid biopsy testing followed by low-dose CT (LDCT) thorax screening as per the study protocol. Participants with positive liquid biopsy results and negative LDCT findings will be offered a study-funded CT-PET scan for further evaluation.

Diagnostic Test: Liquid Biopsy (SPOT-MAS Assay)Diagnostic Test: Exosome-Based Liquid Biopsy AssayDiagnostic Test: Low-Dose CT Thorax (LDCT)

Early-Stage Lung Cancer Patients (Stage I-II)

EXPERIMENTAL

Participants with histologically confirmed early-stage lung cancer (Stage I-II) undergo blood collection for liquid biopsy testing to evaluate assay performance in early disease.

Diagnostic Test: Liquid Biopsy (SPOT-MAS Assay)Diagnostic Test: Exosome-Based Liquid Biopsy Assay

Advanced-Stage Lung Cancer Patients (Stage III-IV)

EXPERIMENTAL

Participants with histologically confirmed advanced-stage lung cancer (Stage III-IV) undergo blood collection for liquid biopsy testing to evaluate assay performance in advanced disease.

Diagnostic Test: Liquid Biopsy (SPOT-MAS Assay)Diagnostic Test: Exosome-Based Liquid Biopsy Assay

Interventions

Liquid Biopsy (SPOT-MAS Assay)DIAGNOSTIC_TEST

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

Advanced-Stage Lung Cancer Patients (Stage III-IV)Early-Stage Lung Cancer Patients (Stage I-II)High-Risk Individuals Without Known Lung Cancer
Exosome-Based Liquid Biopsy AssayDIAGNOSTIC_TEST

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

Advanced-Stage Lung Cancer Patients (Stage III-IV)Early-Stage Lung Cancer Patients (Stage I-II)High-Risk Individuals Without Known Lung Cancer
Low-Dose CT Thorax (LDCT)DIAGNOSTIC_TEST

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

High-Risk Individuals Without Known Lung Cancer

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • +1 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital Singapore

Singapore, 119228, Singapore

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

BiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SEQUENTIAL
Model Details: Participants are assigned to protocol-defined diagnostic procedures based on cohort classification (high-risk individuals without lung cancer, early-stage lung cancer patients, or advanced-stage lung cancer patients). High-risk participants undergo liquid biopsy testing followed by LDCT screening, with CT-PET performed if liquid biopsy results are positive and LDCT findings are negative. Cancer cohorts undergo liquid biopsy testing only.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Lee Soo Chin

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 22, 2026

Study Start

November 1, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)