Biopsy Technique, CT Guided Puncture Biopsy, NGS, NSCLC, VATS
Conditions
Keywords
NSCLC, biopsy technique, VATS, CT guided puncture biopsy, NGS
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.
Interventions
DIAGNOSTIC_TESTvats
Use uniportal tubeless VATS to obtain the biopsy
DIAGNOSTIC_TESTCT-guided fine needle biopsy
Use CT-guided fine needle to obtain the biopsy
Sponsors
Jianxing He
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualified Rate of Biopsy for Second-generation Tibial Specimens | up to 2 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Progression Free Survival | up to 2 years | Progression Free Survival of patients under different biopsy methods |
| Correlation between tumor cell content and detection rate of sensitive mutations | up to 2 years | — |
| Tumor Content Size | up to 2 years | Tumor Content of patients under different biopsy methods |
| Gene Mutation Rate | up to 2 years | Gene Mutation Rate of patients under different biopsy methods |
| Drug sensitive mutation detection rate | up to 2 years | Drug sensitive mutation detection rate of patients under different biopsy methods |
| Detection of PD-L1 expression | up to 2 years | Detection of PD-L1 expression of patients under different biopsy methods |
| TMB detection situation | up to 2 years | TMB detection situation of patients under different biopsy methods |
| Overall Survival | up to 2 years | Overall Survival of patients under different biopsy methods |
Outcome results
None listed