Lung Cancer
Conditions
Keywords
ablation, circulating free DNA, methylation
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.
Interventions
OTHERablation
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 ).
OTHERsurgery
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).
Sponsors
Shanghai Chest Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18-85 years old; 2. The peripheral pulmonary nodules found in patients with chest CT, preoperative examination showed that the clinical stage of patients was T1N0M0, IA; 3. patients are not suitable for surgical treatment through multidisciplinary assessment, agree to accept ablation 4. Patients have good compliance with the tests and follow-ups, understand the situation of the study and sign informed consent.
Exclusion criteria
1. The patient is generally in poor condition and cannot tolerate the examination; 2. patients with a cardiac pacemaker or stent in the heart; peripheral tumors of the lungs are adjacent to large blood vessels or important structures; 3. patients with poor compliance; 4. Researchers believe that it is not appropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed