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

NCT04950907 | Unknown

• 1 other identifier: 20210301
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

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.

Conditions

NSCLC; Biopsy Technique; VATS; CT Guided Puncture Biopsy; NGS

Keywords

NSCLC; biopsy technique; VATS; CT guided puncture biopsy; NGS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Progression Free Survival

  up to 2 years

• Overall Survival

  up to 2 years

• Tumor Content Size

  up to 2 years

• Gene Mutation Rate

  up to 2 years

• Drug sensitive mutation detection rate

  up to 2 years

Study Arms (2)

treatment

EXPERIMENTAL

Uniportal VATS biopsy

Diagnostic Test: vats

control

ACTIVE COMPARATOR

CT-guided fine needle biopsy

Diagnostic Test: CT-guided fine needle biopsy

Interventions

vats DIAGNOSTIC_TEST

Use uniportal tubeless VATS to obtain the biopsy

treatment

CT-guided fine needle biopsy DIAGNOSTIC_TEST

Use CT-guided fine needle to obtain the biopsy

control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jianxing He: lead

MeSH Terms

Interventions

Thoracic Surgery, Video-Assisted

Intervention Hierarchy (Ancestors)

Thoracoscopy; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Video-Assisted Surgery; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: July 6, 2021
• Study Start: July 15, 2021
• Primary Completion: June 26, 2023
• Study Completion: June 26, 2024
• Last Updated: July 13, 2021

Record last verified: 2021-07