Application Research of Methylation Markers in Early-stage Lung Cancer Patients Treated With Co-ablation System Therapy

NCT07257471 | Recruiting

• 1 other identifier: M202552
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Lung cancer has the highest global incidence and mortality among malignancies. While surgery is the primary curative treatment for early-stage patients, approximately 25-35% are ineligible due to comorbidities. For these patients, Co-ablation system therapy is a key minimally invasive option. However, even after imaging indicates complete tumor removal ("tumor-free status"), minimal residual disease (MRD) may persist, leading to recurrence. Current mainstream MRD detection relies on identifying mutations in circulating tumor DNA (ctDNA). This approach faces challenges like high mutational heterogeneity and the frequent need for tumor tissue sequencing (Tumor-informed). In contrast, DNA methylation markers offer advantages: they do not require prior knowledge of tumor mutations, appear early in tumorigenesis, are tissue-specific, and allow sensitive detection via multiple consistent CpG sites. Recent studies confirm that ctDNA methylation-based MRD detection can predict recurrence in lung and colorectal cancers earlier than imaging and effectively stratify patient risk. This study aims to investigate the role of SHOX2 and PTGER4 genes in plasma, for monitoring MRD and evaluating therapeutic efficacy in lung cancer patients after Co-ablation system therapy. The study will enroll non-small cell lung cancer (NSCLC) patients undergoing Co-ablation system therapy. Peripheral blood will be collected at multiple timepoints (pre-treatment up to 24 months post-treatment) for ctDNA methylation analysis. The correlation between methylation levels and radiological findings will be assessed. The predictive power for recurrence will be evaluated using ROC curves. Patients will be stratified into high-risk and low-risk groups based on methylation status. Kaplan-Meier survival analysis and Cox regression models will compare recurrence-free survival between groups and evaluate the independent predictive value of SHOX2/PTGER4 methylation for recurrence risk, providing a scientific basis for personalized treatment decisions and recurrence prediction.

Conditions

Lung Cancer (NSCLC)

Keywords

Liquid biopsy; ctDNA; Methylation biomarker; Prognostic monitoring; MRD; Co-ablation system therapy; Therapeutic efficacy evaluation

Outcome Measures

Primary Outcomes (3)

• The median lead time of SHOX2/PTGER4 methylation compared with traditional methods (tumor markers, imaging) for prediction.

  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).

  Through study completion, an average of 2 years.

• Disease-free survival: Differences in DFS based on methylation status after treatment.

  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.

  Through study completion, an average of 2 years.

• Dynamic concentration changes: The relative change rate of methylation levels before and after treatment and during recurrence.

  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).

  Through study completion, an average of 2 years.

Secondary Outcomes (3)

• The rate of methylation "turning negative" after treatment

  Through study completion, an average of 2 years.

• The relationship between methylation status and overall survival.

  Through study completion, an average of 2 years.

• Forecast performance

  Through study completion, an average of 2 years.

Study Arms (1)

Co-ablation system therapy group

Lung cancer patients are treated with Co-ablation system therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with non-small cell lung cancer (NSCLC) diagnosed by histopathology/clinical diagnosis and scheduled for Co-ablation system therapy were selected, with ages ranging from 18 to 85 years old. All enrolled patients had peripheral blood drawn within one week before treatment, and at 3 days, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months after treatment for the detection of SHOX2/PTGER4 methylation in plasma circulating tumor DNA (ctDNA).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Haidian Hospital: lead

Study Sites (1)

Beijing Haidian Hospital

Beijing, Beijing Municipality, 100080, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral Blood

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Yuqing Huang

  Beijing Haidian Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuqing Huang, Ph.D

CONTACT

+86 13371735630; huangyuqing555@qq.com

Hui Liu, Ph.D

CONTACT

+86 82693657; hdyyllbgs@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 2, 2025
• Study Start: June 6, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)