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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Experimental | Uniportal VATS biopsy |
|
| control | Active Comparator | CT-guided fine needle biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vats | Diagnostic Test | Use uniportal tubeless VATS to obtain the biopsy |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D020775 | Thoracic Surgery, Video-Assisted |
| ID | Term |
|---|---|
| D013906 | Thoracoscopy |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
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| CT-guided fine needle biopsy |
| Diagnostic Test |
Use CT-guided fine needle to obtain the biopsy |
|
| 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 |
| D003933 | Diagnosis |
| D020535 | Video-Assisted Surgery |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019616 | Thoracic Surgical Procedures |