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

NSCLC Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04950907
• Other study ID #: 20210301
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 15, 2021
• Est. completion date: June 26, 2024

Study information

• Verified date: July 2021
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 94
• Est. completion date: June 26, 2024
• Est. primary completion date: June 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC

Intervention

Diagnostic Test:
• vats
Use uniportal tubeless VATS to obtain the biopsy
• CT-guided fine needle biopsy
Use CT-guided fine needle to obtain the biopsy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jianxing He

Outcome

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