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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04950907
Other study ID # 20210301
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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