Clinical trial · Observational
Monitoring of Circulating Tumor DNA and Its Aberrant Methylation in the Surveillance of Surgical Lung Cancer Patients (MEDAL, MEthylation Based Dynamic Analysis for Lung Cancer).
A Prospective Study of Longitudinal Monitoring in Surgical Lung Cancer Patients by Circulating Tumor DNA and Its Methylation
NCT03634826CI-TRIAL-00045692MEDALunknownClinicalTrials.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)
Conduct a prospective study to confirm the value of circulating tumor DNA and its aberrant methylation in longitudinal monitoring of surgical lung cancer patients.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung Neoplasm | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Correlation between patients' recurrence and quantitative detection of circulating tumor DNA (ctDNA) concentration, including the quantitative detection of ctDNA mutations and ctDNA aberrant methylation.
- timeFrame
- 3 years
Secondary outcomes (4)
- measure
- The concordance of ctDNA genomic and methylation status alterations detected in peripheral blood samples with those in matched tumor samples.
- timeFrame
- 1 year
- description
- Concordance will be defined as matched ctDNA and tumor DNA has the same identified mutations (methylation status alterations) or has no mutation (methylation status alteration). Concordance rate (%) will be calculated by consistent patient number and total patient number.
- measure
- The variation of aberrant methylated ctDNA concentration before surgery, 3 days after surgery and 1 month after surgery.
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: Aged 18 to 80 years * Lung cancer was suspected preoperatively. * Received curative surgical therapy * No malignant tumor history within the past 5 years * No being received any treatment prior to resection * Patients must have given written informed consent Exclusion Criteria: * The pulmonary nodule is pure ground glass opacity * Unable to comply with the study procedure * The postoperative pathology is not NSCLC. * Unqualified blood samples
References
Publications (2)
- DERIVEDChen K, Kang G, Zhang Z, Lizaso A, Beck S, Lyskjaer I, Chervova O, Li B, Shen H, Wang C, Li B, Zhao H, Li X, Yang F, Kanu N, Wang J. Individualized dynamic methylation-based analysis of cell-free DNA in postoperative monitoring of lung cancer. BMC Med. 2023 Jul 14;21(1):255. doi: 10.1186/s12916-023-02954-z. PMID 37452374
- DERIVEDKang G, Chen K, Yang F, Chuai S, Zhao H, Zhang K, Li B, Zhang Z, Wang J. Monitoring of circulating tumor DNA and its aberrant methylation in the surveillance of surgical lung Cancer patients: protocol for a prospective observational study. BMC Cancer. 2019 Jun 13;19(1):579. doi: 10.1186/s12885-019-5751-9. PMID 31195991