Clinical trial · Observational
Diagnostic and Monitoring Significance of ctDNA Methylation Analysis by NGS in Benign and Malignant Pulmonary Nodules
Diagnostic and Monitoring Significance of Circulating Tumor DNA (ctDNA) Methylation Analysis by Next-Generation Sequencing in Benign and Malignant Pulmonary Nodules
NCT03651986CI-TRIAL-00066654unknownClinicalTrials.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)
AnchorDx is using circulating tumor DNA (ctDNA) methylation analysis by next-generation sequencing (NGS) to develop a blood-based assay for differentiating benign and malignant pulmonary nodules early. The purpose of this study is to evaluate the diagnostic performance of this assay in patients with pulmonary nodules.
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 Nodules | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ctDNA methylation analysis by NGS | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Prospective Cohort
- description
- This is a prospectively enrolling cohort study and a stratified case-cohort design will be employed to select malignant pulmonary nodules cases and benign pulmonary nodules subjects who will be assayed. All participants will be followed up with chest CT or low-dose computed tomography (LDCT) scans for 2-3 years, and take the diagnostic test, ctDNA methylation analysis by NGS, at each visit.
- interventionNames
- Diagnostic Test: ctDNA methylation analysis by NGS
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
- 3 Years
- description
- The efficacy of the blood-based ctDNA methylation assay comparing with pathologic diagnosis, the gold standard, and CT/LDCT diagnosis, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 Years and older * pulmonary nodules diagnosed by chest CT or low-dose computed tomography (LDCT) scans * non-calcified pulmonary nodules with the diameter between 5mm to 30mm * including solid nodules, mixed ground-glass opacity nodules and pure ground-glass opacity lung modules * new cases of pulmonary nodules or diagnosed within 60 days prior to enrollment * agree to finish the Patient Pulmonary History Questionnaire * agree to be followed up for 2-3 years * agree to provide a written informed consent Exclusion Criteria: * pregnant or lactating women * received any pneumonectomy or percutaneous lung biopsy before enrollment * recipients of blood transfusions within 30 days prior to enrollment * patients with tumors identified within 2 years prior to enrollment except non-melanoma skin cancer * fail to understand or provide a written informed consent
References
Publications (3)
- 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
- DERIVEDLiang W, Liu D, Li M, Wang W, Qin Z, Zhang J, Zhang Y, Hu Y, Bao H, Xiang Y, Wang B, Wu J, Sun J, Hu C, Ye X, Zhang X, Xiao W, Yun C, Sun D, Wang W, Chang N, Zhang Y, Zhao J, Zhang X, Xu J, Wu D, Liu X, Guo Y, Zhang Q, Zhang W, Yang L, Li Z, Zhang X, Han B, Tong Z, He J, Qu J, Fan JB, Zhong N. Evaluating the diagnostic accuracy of a ctDNA methylation classifier for incidental lung nodules: protocol for a prospective, observational, and multicenter clinical trial of 10,560 cases. Transl Lung Cancer Res. 2020 Oct;9(5):2016-2026. doi: 10.21037/tlcr-20-701. PMID 33209621