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

NCT ID: NCT04950907

Last Updated: 2021-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-15

Study Completion Date

2024-06-26

Brief Summary

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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

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Conditions

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NSCLC Biopsy Technique VATS CT Guided Puncture Biopsy NGS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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treatment

Uniportal VATS biopsy

Group Type EXPERIMENTAL

vats

Intervention Type DIAGNOSTIC_TEST

Use uniportal tubeless VATS to obtain the biopsy

control

CT-guided fine needle biopsy

Group Type ACTIVE_COMPARATOR

CT-guided fine needle biopsy

Intervention Type DIAGNOSTIC_TEST

Use CT-guided fine needle to obtain the biopsy

Interventions

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vats

Use uniportal tubeless VATS to obtain the biopsy

Intervention Type DIAGNOSTIC_TEST

CT-guided fine needle biopsy

Use CT-guided fine needle to obtain the biopsy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jianxing He

OTHER

Sponsor Role lead

Responsible Party

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Jianxing He

Prof.

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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20210301

Identifier Type: -

Identifier Source: org_study_id

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