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

Not Applicable

• Conditions: Lung Cancer

• 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.

Study Timeline

• Status Verified: 2019-06
• Study Start: 2019-06-17
• Study First Submitted: 2019-11-11
• Study First Submitted QC: 2020-05-28
• Last Update Submitted: 2020-05-28
• Study First Posted: 2020-06-04
• Last Update Posted: 2020-06-04
• Primary Completion: 2020-12-17
• Study Completion: 2021-06-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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