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

Shanghai Chest Hospital90 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Cancer

Interventions

ablationOTHER

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 ).

surgeryOTHER

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: before surgery , after surgery 1month, 3month, 6month，9month，12month，18month and 24month

Secondary Outcomes

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

Time frame: before surgery , after surgery 1month, 3month

Data from ClinicalTrials.gov

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