Actively Recruiting
Application of Methylation Markers in Early Detection and MRD Monitoring of Lung Cancer
Led by Beijing Haidian Hospital · Updated on 2025-12-02
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the use of combined plasma SHOX2 and PTGER4 gene methylation analysis as a biomarker to monitor minimal residual disease (MRD) and predict recurrence in patients with non-small cell lung cancer (NSCLC) after surgery. It focuses on whether regular methylation assessments can help guide personalized treatment decisions by identifying high-risk patients, potentially reducing overtreatment or undertreatment. The study enrolls stage I-IV NSCLC patients who undergo surgical tumor removal. Patients receive standard surgical treatment for NSCLC. Peripheral blood samples are collected at multiple timepoints: before surgery, 3 days after, and at 1, 3, 6, 9, 12, 18, and 24 months post-surgery, as well as if cancer recurrence occurs. These samples are tested for circulating tumor DNA (ctDNA) methylation of SHOX2 and PTGER4 genes to track changes over time. This observational study does not administer additional treatments but closely monitors methylation markers and tumor markers. Participants provide blood samples and clinical data over about two years. Researchers analyze relationships between methylation levels and imaging results, recurrence risk, and survival outcomes. They use statistical methods to classify patients by risk and assess the predictive value of methylation markers for disease-free survival and overall survival. The study aims to establish if ctDNA methylation testing can become a standard tool for managing postoperative NSCLC by detecting MRD and guiding treatment decisions.
CONDITIONS
Brief Title
Application of Methylation Markers in Early Detection and MRD Monitoring of Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with non-small cell lung cancer (NSCLC) by histopathology or clinical diagnosis
- Age between 18 and 85 years old
- Determined by clinicians to be eligible for surgical treatment
- ECOG performance score of 2 or less and expected survival of at least 6 months
- Clear clinical information available including age, gender, and diagnosis
You will not qualify if you...
- History of other malignant tumors or autoimmune diseases
- Severe heart, lung, or vascular diseases preventing surgery
- Pregnant or lactating women
- Unable to complete follow-up or deemed unsuitable by the researcher
- Incomplete clinical or follow-up information
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day for surgery
Participants undergo surgical resection for non-small cell lung cancer as part of their treatment.
1 visit (in-person) for surgery
Duration - Up to 24 months
Participants have peripheral blood collected at multiple timepoints after surgery to monitor DNA methylation markers for minimal residual disease and recurrence risk.
9 visits (in-person) at 3 days, 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, and upon recurrence
Trial Site Locations
Total: 1 location
1
Beijing Haidian Hospital
Beijing, Beijing Municipality, China, 100080
Actively Recruiting
Research Team
Y
Yuqing Huang, Ph.D
H
Hui Liu, Ph.D
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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