Using blood methylation markers to monitor early-stage NSCLC after Co‑ablation
Official title: Application Research of Methylation Markers in Early-stage Lung Cancer Patients Treated With Co-ablation System Therapy
Run by Beijing Haidian Hospital · NCT07257471 · Data updated 2026-11-12
This project will try a blood methylation test to see if it can find tiny amounts of lung cancer DNA after co‑ablation treatment in people with early-stage non‑small cell lung cancer who cannot have surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Beijing Haidian Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | June 6, 2025 |
| Main results expected | June 30, 2028 |
| Study ends | June 30, 2028 |
| Registry record updated | December 2, 2025 |
| Trial ID | NCT07257471 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (18–85) with early-stage NSCLC who are assessed as unable or unwilling to undergo surgery, have a single tumor within the specified size and location limits, ECOG ≤1, and are methylation‑positive before treatment.
✕Probably not a fit
Patients with other active malignancies or autoimmune disease, pregnant or lactating women, those with metastatic or multiple unresectable nodules, or those who are methylation‑negative before treatment are unlikely to benefit from this monitoring approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study follows early-stage NSCLC patients treated with a Co‑ablation system to measure circulating tumor DNA methylation patterns over time. Blood samples will be collected before and after treatment and during follow‑up to detect minimal residual disease (MRD) without requiring prior tumor sequencing. The study compares methylation-based ctDNA signals with routine imaging and clinical outcomes to see whether methylation predicts recurrence. All enrolled patients meet specific size, functional status, and eligibility criteria and are treated at Beijing Haidian Hospital.
Why it matters
Potential benefit: If successful, the methylation blood test could detect hidden residual cancer earlier than imaging and help target closer follow‑up or additional therapy to reduce recurrence.
How similar studies have gone: Recent research has shown that ctDNA methylation methods can predict recurrence in some cancers and appear promising for MRD detection, though broader validation is still emerging.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with non-small cell lung cancer by histopathology/clinical diagnosis; assessed by MDT as not suitable or refusing open or thoracoscopic resection surgery. * Age 18-85 years old, gender unrestricted. * The maximum diameter of the tumor is ≤ 5 cm (peripheral type) or ≤ 3 cm (central type), and the distance from major blood vessels/trachea is ≥ 1 cm. * Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1, with an expected survival period of ≥ 6 months. * The subjects should have clear case information, including age, gender, and clinical diagnosis, etc. Exclusion Criteria: * Those with a history of other malignant tumors or autoimmune diseases。 * Pregnant or lactating women; or patients with lung cancer who were negative for methylation before treatment. * Patients with clinical or pathological diagnosis of lung metastatic cancer. * Ppatients with multiple nodules and the current treatment cannot completely address all positive nodules. * Patients whose clinical information or follow-up during the study may not be completed; and other factors that the researcher deems unsuitable for participation in this study.
Where it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.