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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04413656
• Other study ID #: SHCHE201902
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2019
• Est. completion date: June 17, 2021

Study information

• Verified date: June 2019
• Source: Shanghai Chest Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 17, 2021
• Est. primary completion date: December 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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 ).
• 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).

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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