Clinical trial · Observational
Liquid Biopsy Using Methylation Sequencing for Lung Cancer
Clinical Utility of Circulating Tumor DNA Methylation in the Diagnosis of Primary Lung Cancer
NCT04253509CI-TRIAL-00056382completedClinicalTrials.gov clinicaltrialsProvenance
- 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 aims to investigate the utility of circulating tumor DNA (ctDNA) methylation sequencing in the diagnosis of primary lung cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diagnoses Disease | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Circulating Tumor DNA Methylation Sequencing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Lung cancer
- interventionNames
- Diagnostic Test: Circulating Tumor DNA Methylation Sequencing
- label
- Benign pulmonary disease
- interventionNames
- Diagnostic Test: Circulating Tumor DNA Methylation Sequencing
Primary outcomes (2)
- measure
- Diagnostic sensitivity of ctDNA methylation sequencing
- timeFrame
- 2 year
- description
- Using pathologic diagnosis of lung cancer as gold standard, diagnostic sensitivity of ctDNA methylation will be compared with that of tumor markers.
- measure
- Diagnostic specificity of ctDNA methylation sequencing
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Lung cancer group 1. Pathologically proven lung cancer 2. Clinically suspected lung cancer on chest CT scan * Benign pulmonary disease group * Chronic obstructive pulmonary disease, interstitial lung disease, pneumonia, bronchiectasis, non-tuberculous mycobacterial lung disease, pulmonary vascular disease Exclusion Criteria: * Patients with previous history of lung cancer * Patients who have been diagnosed with other malignancy within 5 years * Unstable vital status * Active pulmonary tuberculosis * Infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
References
Publications (1)
- DERIVEDKwon HJ, Shin SH, Kim HH, Min NY, Lim Y, Joo TW, Lee KJ, Jeong MS, Kim H, Yun SY, Kim Y, Park D, Joo J, Bae JS, Lee S, Jeong BH, Lee K, Lee H, Kim HK, Kim K, Um SW, An C, Lee MS. Advances in methylation analysis of liquid biopsy in early cancer detection of colorectal and lung cancer. Sci Rep. 2023 Aug 19;13(1):13502. doi: 10.1038/s41598-023-40611-w. PMID 37598236