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Clinical Trials/NCT04413656
NCT04413656
Unknown
Not Applicable

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

Shanghai Chest Hospital1 site in 1 country90 target enrollmentJune 17, 2019
ConditionsLung Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Cancer
Sponsor
Shanghai Chest Hospital
Enrollment
90
Locations
1
Primary Endpoint
Screening and monitoring the change of cfDNA methylation index
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 17, 2019
End Date
June 17, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jiayuan Sun

Chief Physician, Department of Pulmonary Medicine, Director, Department of Respiratory Endoscopy and Interventional Pulmonology

Shanghai Chest Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Screening and monitoring the change of cfDNA methylation index

Time Frame: 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 Outcomes

  • Comparing similarities and differences between cfDNA methylation in surgical treatment and ablation(before surgery , after surgery 1month, 3month)

Study Sites (1)

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