Uniportal Tubeless VATS for the Evaluation of Biopsy for Second-generation Sequencing in Patients With Advanced NSCLC

Not Applicable

• Conditions: VATS; Biopsy Technique; NSCLC; CT Guided Puncture Biopsy; NGS
• Interventions: Diagnostic Test: CT-guided fine needle biopsy; Diagnostic Test: vats

• Registration Number: NCT04950907
• Lead Sponsor: Jianxing He

Brief Summary

The study is a single-center, prospective, open-label randomized controlled study. This study evaluates the eligibility rate of different biopsy methods (tubeless tubeless VATS vs. CT guided fine needle aspiration) for the detection of molecular genetic characteristics of peripheral NSCLC next-generation sequencing, and its main purpose is to evaluate the use of tumor gene profiling (NGS) The best biopsy technique, the First Affiliated Hospital of Guangzhou Medical University is the research center. It is expected to be completed between 2021-3-1 and 2023-3-1.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-14
• Study First Submitted QC: 2021-06-26
• Status Verified: 2021-07
• Study First Posted: 2021-07-06
• Last Update Submitted: 2021-07-10
• Last Update Posted: 2021-07-13
• Study Start: 2021-07-15
• Primary Completion: 2023-06-26
• Study Completion: 2024-06-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• Informed consent is obtained
• Assessed by more than 2 surgeons, patients whose lesions can be achieved by tubeless single-port thoracoscopic surgical biopsy

Exclusion Criteria

• History of other malignant tumors.
• The general condition is not suitable for puncture, bronchoscopy, or surgery (such as cardiopulmonary dysfunction, high risk of bleeding, allergy to anesthetics, confusion, inability to exercise, etc.)
• History of lung surgery, tuberculosis and coal mine work experience, etc. may cause severe chest adhesions; other situations that conflict with the biopsy process

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	CT-guided fine needle biopsy	CT-guided fine needle biopsy
treatment	vats	Uniportal VATS biopsy

Primary Outcome Measures

Name	Time	Method
Qualified Rate of Biopsy for Second-generation Tibial Specimens	up to 2 years	Different biopsy methods (single-port tubeless VATS biopsy vs CT-guided fine-needle aspiration biopsy) are used to evaluate the qualification rate of samples obtained for NGS testing

Secondary Outcome Measures

Name	Time	Method
Tumor Content Size	up to 2 years	Tumor Content of patients under different biopsy methods
Overall Survival	up to 2 years	Overall Survival of patients under different biopsy methods
Gene Mutation Rate	up to 2 years	Gene Mutation Rate of patients under different biopsy methods
TMB detection situation	up to 2 years	TMB detection situation of patients under different biopsy methods
Drug sensitive mutation detection rate	up to 2 years	Drug sensitive mutation detection rate of patients under different biopsy methods
Detection of PD-L1 expression	up to 2 years	Detection of PD-L1 expression of patients under different biopsy methods
Correlation between tumor cell content and detection rate of sensitive mutations	up to 2 years
Perioperative complications	up to 2 years
Postoperative patient experience score	up to 2 years
Usage rate of targeted drug	up to 2 years
Postoperative MRD detection	up to 2 years
Progression Free Survival	up to 2 years	Progression Free Survival of patients under different biopsy methods
Success rate of enrollment	up to 2 years