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

Study Overview
=================
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.

Official Title
-----------------
A Randomized Controlled Study of Single Port Tubeless VATS for the Evaluation of Qualified Rate of Biopsy for Second-generation Tibial Specimens in Patients With Advanced NSCLC

Conditions
-----------------
NGS, NSCLC, Biopsy Technique, VATS, CT Guided Puncture Biopsy

Intervention / Treatment
-----------------
* Diagnostic Test: vats
* Diagnostic Test: CT-guided fine needle biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br>Uniportal VATS biopsy | Diagnostic Test: vats<br>* Use uniportal tubeless VATS to obtain the biopsy<br>|
| Active Comparator: control<br>CT-guided fine needle biopsy | Diagnostic Test: CT-guided fine needle biopsy<br>* Use CT-guided fine needle to obtain the biopsy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualified Rate of Biopsy for Second-generation Tibial Specimens | 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 | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | Progression Free Survival of patients under different biopsy methods | up to 2 years | 
| Overall Survival | Overall Survival of patients under different biopsy methods | up to 2 years | 
| Tumor Content Size | Tumor Content of patients under different biopsy methods | up to 2 years | 
| Gene Mutation Rate | Gene Mutation Rate of patients under different biopsy methods | up to 2 years | 
| Drug sensitive mutation detection rate | Drug sensitive mutation detection rate of patients under different biopsy methods | up to 2 years | 
| Detection of PD-L1 expression | Detection of PD-L1 expression of patients under different biopsy methods | up to 2 years | 
| TMB detection situation | TMB detection situation of patients under different biopsy methods | up to 2 years | 
| 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 | 
| Success rate of enrollment |  | up to 2 years | 
| Postoperative MRD detection |  | up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NSCLC, biopsy technique, VATS, CT guided puncture biopsy, NGS