Using blood methylation markers to detect recurrence and monitor minimal residual disease in lung cancer
Application of Methylation Markers in Early Detection and MRD Monitoring of Lung Cancer
This project will test whether tracking two blood DNA methylation markers (SHOX2 and PTGER4) can detect minimal residual disease and predict recurrence in patients after non-small cell lung cancer surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Beijing Haidian Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07257458 on ClinicalTrials.gov |
What this trial studies
This observational study followed patients with stage I–IV non‑small cell lung cancer who underwent surgical resection and collected peripheral blood before surgery and at multiple timepoints up to 24 months postoperatively to measure SHOX2 and PTGER4 methylation in circulating tumor DNA. Serial methylation levels were compared with conventional tumor markers and imaging to see whether rising methylation signals precede radiographic recurrence. The aim was to identify high‑risk patients who might benefit from personalized adjuvant therapy and to reduce overtreatment or undertreatment. Statistical analyses examined correlations between methylation dynamics and clinical recurrence outcomes.
Who should consider this trial
Good fit: Adults aged 18–85 with histologically or clinically confirmed NSCLC who are eligible for surgical resection, have ECOG ≤2, and can comply with serial blood draws and follow-up are ideal candidates.
Not a fit: Patients with other active malignancies, severe comorbidities that prevent surgery, pregnant or lactating individuals, or those unlikely to complete follow-up or provide adequate samples may not benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could detect recurrence earlier than imaging and help tailor adjuvant therapy to avoid over- or undertreatment.
How similar studies have performed: Previous research has shown that methylation markers including SHOX2 and PTGER4 can detect lung cancer and show promise for MRD monitoring, but large prospective validation for guiding adjuvant therapy remains limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Haidian Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Yuqing Huang — Beijing Haidian Hospital
- Study coordinator: Yuqing Huang, Ph.D
- Email: huangyuqing555@qq.com
- Phone: +86 13371735630
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.