cfDNA Methylation Assay for Clinical Evaluation of Patients With Stage IA Lung Cancer After Ablation Operation

Study Overview
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Brief Summary
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The objective is to screen and monitor the efficacy of cfDNA methylation in patients with stage I lung cancer after ablation, to compare the similarities and differences of cfDNA methylation between surgical treatment and ablation in patients with stage I lung cancer, and to look for new indicators to assess the efficacy of ablation therapy and to monitor lung cancer recurrence.

Detailed Description
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The objective is to screen and monitor the efficacy of cfDNA methylation in patients with stage I lung cancer after ablation, to compare the similarities and differences of cfDNA methylation between surgical treatment and ablation in patients with stage I lung cancer, and to look for new indicators to assess the efficacy of ablation therapy and to monitor lung cancer recurrence. The main research content is to screen the cfDNA methylation index that can monitor the efficacy of stage I lung cancer ablation and compare the similarities and differences of cfDNA methylation in patients with stage I lung cancer after surgery and ablation.

Official Title
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cfDNA Methylation Assay for Clinical Evaluation of Patients With Stage IA Lung Cancer After Ablation Operation

Conditions
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Lung Cancer

Intervention / Treatment
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* Other: ablation
* Other: surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-85 years old; The peripheral pulmonary nodules found in patients with chest CT, preoperative examination showed that the clinical stage of patients was T1N0M0, IA; patients are not suitable for surgical treatment through multidisciplinary assessment, agree to accept ablation Patients have good compliance with the tests and follow-ups, understand the situation of the study and sign informed consent. Exclusion Criteria: The patient is generally in poor condition and cannot tolerate the examination; patients with a cardiac pacemaker or stent in the heart; peripheral tumors of the lungs are adjacent to large blood vessels or important structures; patients with poor compliance; Researchers believe that it is not appropriate to participate in this trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ablation group<br>Patients with stage IA inoperable peripheral lung tumor will be performed ablation. cfDNA methylation would be monitored at different times(before surgery , after surgery 1month, 3month, and every 3month in the first year and every 6 months in the second ). Meanwhile, post-treatment response will be evaluated and follow up will be carried out according to the standard procedure. | Other: ablation<br>* Patients with stage IA inoperable peripheral lung tumor will be performed ablation. cfDNA methylation would be monitored at different times(before surgery , after surgery 1month, 3month, and every 3month in the first year and every 6 months in the second ).<br>|
| Experimental: surgery group<br>Patients with stage IA operable peripheral lung tumor will be performed surgery. cfDNA methylation would be monitored at different time(before surgery , after surgery 1month, 3month). Post-treatment response will be evaluated and follow up will be carried out according to the standard procedure. | Other: surgery<br>* Patients with stage IA inoperable peripheral lung tumor will be performed ablation. cfDNA methylation would be monitored at different times(before surgery, after surgery 1month, 3month).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screening and monitoring the change of cfDNA methylation index | Screening and monitoring the change of cfDNA methylation index in patients with stage I lung cancer after ablation | before surgery , after surgery 1month, 3month, 6month，9month，12month，18month and 24month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing similarities and differences between cfDNA methylation in surgical treatment and ablation | Comparing similarities and differences between cfDNA methylation in surgical treatment and ablation of patients with stage I lung cancer | before surgery , after surgery 1month, 3month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ablation, circulating free DNA, methylation