NCT07257458Recruiting
Application of Methylation Markers in Early Detection and MRD Monitoring of Lung Cancer
Source: ClinicalTrials.gov · Last updated 2 Dec 2025
Brief summary (registry, in English)
This study aims to evaluate the utility of combined plasma SHOX2 and PTGER4 gene methylation analysis as a dynamic biomarker for monitoring minimal residual disease (MRD) and predicting recurrence in postoperative non-small cell lung cancer (NSCLC) patients. The primary objective is to determine whether serial methylation assessment can guide personalized adjuvant therapy decisions by identifying high-risk individuals, thereby potentially reducing overtreatment or undertreatment. Stage I-IV NSCLC patients undergoing surgical resection were enrolled. Peripheral blood was collected longitudinally for circulating tumor DNA (ctDNA) methylation testing: preoperatively, postoperatively at 3 days, 1, 3, 6, 9, 12, 18, and 24 months, and upon radiographic recurrence. The dynamic changes in SHOX2/PTGER4 methylation levels and conventional tumor marker positivity rates were analyzed. Comprehensive statistical analyses were performed: Correlation between methylation levels and radiographic findings was assessed using Pearson/Spearman tests; predictive accuracy for recurrence was evaluated via ROC curve analysis; patients were stratified into methylation-based risk groups; survival differences were compared using Kaplan-Meier curves with log-rank testing; independent predictive value was determined through multivariate Cox regression adjusting for clinicopathological confounders. Final efficacy assessment integrated ctDNA positivity timing, disease-free survival (DFS), and overall survival (OS) metrics. This prospective biomarker study seeks to validate a novel epigenetic approach for postoperative management, potentially establishing ctDNA methylation monitoring as a standardized tool for MRD detection and recurrence risk stratification in resected NSCLC.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 17 Nov 2025
- Start date
- 2 Apr 2025
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Beijing Haidian Hospital
- Diseases
- Lung cancer
- NCT number
- NCT07257458
What you commit to
- Study type: Observational
- Planned participants: 30
- From 2 Apr 2025 to the primary completion date, 30 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with a history of other malignant tumors or autoimmune diseases.
- Those with severe heart, lung or vascular diseases that make them unable to tolerate surgery.
Other
- Pregnant or lactating women.
- Patients who may be unable to complete follow-up during the study, as well as other factors that the researcher deems inappropriate for participation in the study.
- Incomplete clinical or follow-up information.
Who the study is looking for
- Diagnosed with non-small cell lung cancer (NSCLC) by histopathology/clinical diagnosis.
- Age 18-85 years old.
- Lung cancer patients who are determined by clinicians to be eligible for surgical treatment.
- ECOG score ≤ 2, with an expected survival period of ≥ 6 months, and having signed the informed consent form.
- The subjects should have clear case information, including age, gender, and clinical diagnosis, etc.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Haidian Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.