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

NCT04413656 | Unknown

• 1 other identifier: SHCHE201902
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

ablation; circulating free DNA; methylation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comparing similarities and differences between cfDNA methylation in surgical treatment and ablation

  before surgery , after surgery 1month, 3month

Study Arms (2)

ablation group

EXPERIMENTAL

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

surgery group

EXPERIMENTAL

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

Interventions

ablation OTHER

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 ).

ablation group

surgery OTHER

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).

surgery group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Department of Pulmonary Medicine, Director, Department of Respiratory Endoscopy and Interventional Pulmonology

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: June 4, 2020
• Study Start: June 17, 2019
• Primary Completion: December 17, 2020
• Study Completion: June 17, 2021
• Last Updated: June 4, 2020

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)