Actively Recruiting

Age: 18Years - 85Years
All Genders
ID07257471

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

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

Lung cancer, particularly non-small cell lung cancer (NSCLC), is one of the most common and deadly cancers worldwide. Surgery is the main curative treatment for early-stage patients; however, some patients cannot undergo surgery due to other health issues. For these patients, Co-ablation system therapy offers a minimally invasive treatment option. Despite imaging showing complete tumor removal, minimal residual disease (MRD) may remain, potentially causing recurrence. This study investigates how methylation markers of the SHOX2 and PTGER4 genes in blood can monitor MRD and evaluate treatment effectiveness after Co-ablation therapy in NSCLC patients. Participants will undergo Co-ablation system therapy followed by blood sample collection at multiple time points: before treatment, then at 3 days, and 1, 3, 6, 12, 18, and 24 months after treatment. These samples will be analyzed for methylation levels of the SHOX2 and PTGER4 genes to detect MRD. The study will compare methylation results with imaging and tumor marker tests to assess how well methylation predicts recurrence and therapeutic response. Patients will be grouped into high-risk or low-risk categories based on methylation status. Throughout the study, researchers will track changes in methylation over time and measure outcomes like disease-free survival and recurrence rates. They will also evaluate the time methylation markers predict recurrence compared with traditional methods. Participants will be monitored for up to two years after treatment. The study aims to provide a scientific basis for personalized treatment plans and early detection of lung cancer recurrence.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with non-small cell lung cancer by histopathology or clinical diagnosis
  • Assessed as not suitable for or refusing open or thoracoscopic lung surgery
  • Age between 18 and 85 years, any gender
  • Tumor size 5 cm or smaller if peripheral, or 3 cm or smaller if central
  • Tumor at least 1 cm away from major blood vessels or trachea
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Expected survival period of at least 6 months
  • Clear case information including age, gender, and clinical diagnosis available
Not Eligible

You will not qualify if you...

  • History of other malignant tumors or autoimmune diseases
  • Pregnant or breastfeeding women
  • Lung cancer patients negative for methylation before treatment
  • Clinical or pathological diagnosis of lung metastatic cancer
  • Multiple nodules not fully treatable by current therapy
  • Incomplete clinical information or follow-up
  • Other factors deemed unsuitable by the researcher

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single treatment visit

Participants receive Co-ablation system therapy as a local treatment for non-small cell lung cancer.

1 visit (in-person)

Long-term Monitoring

Duration - 24 months

Participants have peripheral blood samples collected at multiple time points after treatment to monitor DNA methylation markers as indicators of minimal residual disease and recurrence risk.

7 visits at 3 days, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months after treatment

Trial Site Locations

Total: 1 location

1

Beijing Haidian Hospital

Beijing, Beijing Municipality, China, 100080

Actively Recruiting

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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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