Application of Methylation Markers in Early Detection and MRD Monitoring of Lung Cancer

Recruiting now

Conditions studied: Lung Cancer (NSCLC)

In brief

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.

Key facts

Study ID

NCT07257458

Run by

Beijing Haidian Hospital

People needed

30

Starts

2025-04-02

Expected to finish

2028-06-30

Last updated by the study team

2025-12-02

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• Beijing Haidian Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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