Clinical trial · Observational
Circulating Tumor DNA Methylation Test to Differentiate Benign and Malignant Pulmonary Nodules
Multi-centers Validation of a Circulating Tumor DNA Assay to Differentiate Benign and Malignant Pulmonary Nodules Via Targeted High-throughput DNA Methylation Sequencing
- 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)
Current state-of-the-art lung cancer early screening utilizes low-dose CT scan to identify lung nodules smaller than 3 cm in diameter. However, it's still a clinical challenge to differentiate between malignant and benign nodules. In previous studies, the investigators had taken the approach of methylation profiling by high throughput bisulfite DNA sequencing in tissue samples to identify specific methylation signatures. The investigators had learned methylation patterns that differentiate malignant vs. benign lesions from tissue samples by in-depth data mining, and then used pattern matching to classify plasma samples. In this study, the investigators are going to validate the efficacy of ctDNA methylation test for diagnosing early lung cancer by comparing results of the pre-surgery ctDNA methylation test with the post-surgery pathology.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pulmonary Nodule, Solitary | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Circulating Tumor DNA Methylation Test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The diagnostic performance of the blood-based assay for differentiating benign and malignant pulmonary nodules early using circulating tumor DNA (ctDNA) methylation analysis by next-generation sequencing (NGS)
- timeFrame
- 1 year
- description
- The efficacy of the blood-based ctDNA methylation assay comparing with pathologic diagnosis, the gold standard, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years old or above * single pulmonary nodule found by CT scan. * the diameter of the pulmonary nodule is between 5mm to 30mm. * plan to accept pneumonectomy due to the pulmonary nodule. * without any sign of lymphatic or distant metastasis. * agree to sign informed consent. Exclusion Criteria: * pregnant or lactating women. * the diameter of the pulmonary nodule is more than 30mm * there are 2 or more pulmonary nodules in one single patient. * any sign of lymphatic or distant metastasis
References
Publications (2)
- DERIVEDZeng F, Wang B, Peng M, Tao J, Tu X, Lu H, Qiu X, Yang Y, Wang W, Zeng M, Fan JB, Zeng Q, Liu Q. Comparison of clinical-radiological and radiomics features for predicting pulmonary nodule malignancy in a multicenter study of mixed clinical and surveillance populations. Eur Radiol. 2026 Jul;36(7):6179-6192. doi: 10.1007/s00330-026-12437-3. Epub 2026 Mar 14. PMID 41831027
- DERIVEDLiang W, Tao J, Cheng C, Sun H, Ye Z, Wu S, Guo Y, Zhang J, Chen Q, Liu D, Liu L, Tian H, Teng L, Zhong N, Fan JB, He J. A clinically effective model based on cell-free DNA methylation and low-dose CT for risk stratification of pulmonary nodules. Cell Rep Med. 2024 Oct 15;5(10):101750. doi: 10.1016/j.xcrm.2024.101750. Epub 2024 Sep 27. PMID 39341207