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

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ablation
surgery
Sponsored by
Shanghai Chest Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring ablation, circulating free DNA, methylation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Chest HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ablation group

surgery group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 11, 2019
Last Updated
May 28, 2020
Sponsor
Shanghai Chest Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04413656
Brief Title
cfDNA Methylation Assay for Clinical Evaluation of Patients With Stage IA Lung Cancer After Ablation Operation
Official Title
cfDNA Methylation Assay for Clinical Evaluation of Patients With Stage IA Lung Cancer After Ablation Operation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 17, 2019 (Actual)
Primary Completion Date
December 17, 2020 (Anticipated)
Study Completion Date
June 17, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Chest Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
ablation, circulating free DNA, methylation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ablation group
Arm Type
Experimental
Arm Description
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.
Arm Title
surgery group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
ablation
Intervention Description
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 ).
Intervention Type
Other
Intervention Name(s)
surgery
Intervention Description
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).
Primary Outcome Measure Information:
Title
Screening and monitoring the change of cfDNA methylation index
Description
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 Outcome Measure Information:
Title
Comparing similarities and differences between cfDNA methylation in surgical treatment and ablation
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Shanghai Chest Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiayuan Sun, MD, PhD
Phone
86-021-22200000-1501
Email
jysun1976@163.com
First Name & Middle Initial & Last Name & Degree
Jiayuan Sun, MD, PhD
Phone
18017321598
Email
jysun1976@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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