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

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.

Study Overview

• Status: Unknown
• Conditions: Lung Cancer
• Intervention / Treatment: Other: ablation; Other: surgery

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Shanghai Chest Hospital
      • Contact: Jiayuan Sun, MD, PhD; Phone Number: 86-021-22200000-1501; Email: jysun1976@163.com
      • Contact: Jiayuan Sun, MD, PhD; Phone Number: 18017321598; Email: jysun1976@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ablation group; 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.	Other: 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 ).
Experimental: surgery group; 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.	Other: surgery; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	before surgery , after surgery 1month, 3month, 6month，9month，12month，18month and 24month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	before surgery , after surgery 1month, 3month

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2019
• Primary Completion (Anticipated): December 17, 2020
• Study Completion (Anticipated): June 17, 2021

Study Registration Dates

• First Submitted: November 11, 2019
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: May 28, 2020
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: ablation; methylation; circulating free DNA
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: SHCHE201902

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No