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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: NSCLC; VATS; Biopsy Technique; CT Guided Puncture Biopsy; NGS
• Intervention / Treatment: Diagnostic test: vats; Diagnostic test: CT-guided fine needle biopsy

• Study Type: Interventional
• Enrollment (Anticipated): 94
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment; Uniportal VATS biopsy	Diagnostic test: vats; Use uniportal tubeless VATS to obtain the biopsy
Active Comparator: control; CT-guided fine needle biopsy	Diagnostic test: CT-guided fine needle biopsy; Use CT-guided fine needle to obtain the biopsy

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

Collaborators and Investigators

• Sponsor: Jianxing He

Study record dates

Study Major Dates

• Study Start (Anticipated): July 15, 2021
• Primary Completion (Anticipated): June 26, 2023
• Study Completion (Anticipated): June 26, 2024

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: June 26, 2021
• First Posted (Actual): July 6, 2021

Study Record Updates

• Last Update Posted (Actual): July 13, 2021
• Last Update Submitted That Met QC Criteria: July 10, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: NSCLC; VATS; NGS; biopsy technique; CT guided puncture biopsy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 20210301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No