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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
The median lead time of SHOX2/PTGER4 methylation compared with traditional methods (tumor markers, imaging) for prediction. — Through study completion, an average of 2 years. Measure time point of outcome: Preoperatively, 3 days, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months postoperatively, and at the time of recurrence.
Measure method: SHOX2/PTGER4 Methylation Detection Kit (PCR Fluorescence Method).
Disease-free survival: Differences in DFS based on methylation status after treatment. — Through study completion, an average of 2 years. Measure time point of outcome: Preoperatively, 3 days, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months postoperatively, and at the time of recurrence.
Measure method: Kaplan-Meier method.
Dynamic concentration changes: The relative change rate of methylation levels before and after treatment and during recurrence. — Through study completion, an average of 2 years. Measure time point of outcome: Preoperatively, 3 days, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months postoperatively, and at the time of recurrence.
Measure method: SHOX2/PTGER4 Methylation Detection Kit (PCR Fluorescence Method).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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