Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Screening | — | UNRESOLVED | — |
| Early Lung Cancer Detection | — | UNRESOLVED | — |
| High-Risk Populations | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exosome-Based Liquid Biopsy Assay | Diagnostic Test | — | UNRESOLVED |
| Liquid Biopsy (SPOT-MAS Assay) | Diagnostic Test | — | UNRESOLVED |
| Low-Dose CT Thorax (LDCT) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- High-Risk Individuals Without Known Lung Cancer
- description
- 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.
- interventionNames
- Diagnostic Test: Liquid Biopsy (SPOT-MAS Assay)
- Diagnostic Test: Exosome-Based Liquid Biopsy Assay
- Diagnostic Test: Low-Dose CT Thorax (LDCT)
- type
- EXPERIMENTAL
- label
- Early-Stage Lung Cancer Patients (Stage I-II)
- description
- 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.
- interventionNames
- Diagnostic Test: Liquid Biopsy (SPOT-MAS Assay)
- Diagnostic Test: Exosome-Based Liquid Biopsy Assay
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available