NCT07257458 Application of Methylation Markers in Early Detection and MRD Monitoring of Lung Cancer
| NCT ID | NCT07257458 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Haidian Hospital |
| Condition | Lung Cancer (NSCLC) |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-04-02 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2025-04-02 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 Criteria
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.
Contact & Investigator
Yuqing Huang
PRINCIPAL INVESTIGATOR
Beijing Haidian Hospital
Frequently Asked Questions
Who can join the NCT07257458 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Lung Cancer (NSCLC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07257458 currently recruiting?
Yes, NCT07257458 is actively recruiting participants. Contact the research team at huangyuqing555@qq.com for enrollment information.
Where is the NCT07257458 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07257458 clinical trial?
NCT07257458 is sponsored by Beijing Haidian Hospital. The principal investigator is Yuqing Huang at Beijing Haidian Hospital. The trial plans to enroll 30 participants.
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