cfDNA Methylation Assay for Clinical Evaluation of Patients With Stage IA Lung Cancer After Ablation Operation
- Conditions
- Lung Cancer
- Interventions
- Other: surgeryOther: ablation
- Registration Number
- NCT04413656
- Lead Sponsor
- Shanghai Chest Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description surgery group surgery 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. ablation group ablation 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.
- Primary Outcome Measures
Name Time Method Screening and monitoring the change of cfDNA methylation index before surgery , after surgery 1month, 3month, 6month，9month，12month，18month and 24month Screening and monitoring the change of cfDNA methylation index in patients with stage I lung cancer after ablation
- Secondary Outcome Measures
Name Time Method Comparing similarities and differences between cfDNA methylation in surgical treatment and ablation before surgery , after surgery 1month, 3month Comparing similarities and differences between cfDNA methylation in surgical treatment and ablation of patients with stage I lung cancer
Trial Locations
- Locations (1)
Shanghai Chest Hospital
🇨🇳Shanghai, Shanghai, China