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| Name | Class |
|---|---|
| West China Hospital | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| Capital Medical University | OTHER |
| Jiangsu Raman Medical Equipment Co., Ltd. |
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Compare the data obtained from the Raman analyzer and paraffin pathology examination on the same external brain tissue sample. Evaluate the effectiveness and safety of the Raman analyzer for intraoperative diagnosis gliomas of brain resection tissue samples, using paraffin pathological examination results as clinical reference standards.
Based on statistical calculations,108 positive samples and 148 negative samples will be included in the trial in all trial centers. Compare the results between the Raman analyzer and the paraffin pathological. And calculate the sensitivity, the specificity, and other indicators of Raman analyzer.
During surgery, core or marginal tissue samples were taken from subjects. The test samples size:0.2cm\
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perform two different tests on the same sample | Other | The same sample is diagnosed using a Raman analyzer firstly and then diagnosed by paraffin pathology. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paraffin pathological diagnosis | Diagnostic Test | Perform two diagnostic methods on the same sample |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of the Raman analyzer in detecting gliomar | Among the samples determined by paraffin pathology as gliomas, the percentage of samples detected by Raman analyzer as gliomas. | Through study completion, an average of 1 year |
| Specificity of the Raman analyzer in detecting gliomar | Among the samples determined by paraffin pathology as non gliomas, the percentage of samples detected by the Raman analyzer as non gliomas. | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Using the paraffin test results as a reference, calculate the accuracy of the Raman analyzer in detecting gliomar | The proportion of tissue samples with consistent results between Raman analyzer detection and paraffin pathological diagnosis. | Through study completion, an average of 1 year |
| Positive predictive value of the Raman analyzer in detecting gliomar |
| Measure | Description | Time Frame |
|---|---|---|
| The defect occurrence rate of the Raman analyzer | The proportion of subjects with defects in the Raman analyzer during normal use to the total number of subjects using the Raman analyzer | Through study completion, an average of 1 year |
| Adverse Event Incidence Rate |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tao Jiang, MD and PhD | Contact | +86 10 67021832 | taojiang1964@163.com | |
| Yinyan Wang, MD and PhD | Contact | +86 13581698953 | tiantanyinyan@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Tao Jiang, MD and PhD | Beijing Tiantan Hospital | Principal Investigator |
| Qing Mao | West China Hospital | Principal Investigator |
| Dongming Yan |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| INDUSTRY |
The same sample was diagnosed using Raman spectroscopy and paraffin pathology, respectively. Calculate the sensitivity and specificity of a Raman analyzer using paraffin pathological results as the gold standard.
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Blind assessment: Researchers using Raman analyzer during surgery are not aware of the subjects' preoperative diagnostic results, while researchers conducting paraffin pathology examinations after surgery are not aware of the subjects' preoperative diagnostic results and the diagnostic results of Raman analyzer.
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The percentage of samples diagnosed with glioma by paraffin pathology in the samples detected as glioma by Raman analyzer |
| Through study completion, an average of 1 year |
| Negative predictive value of Raman analyzer in detecting gliomar | The percentage of samples diagnosed with non glioma by paraffin pathology in the samples detected as non glioma by Raman analyzer | Through study completion, an average of 1 year |
| Kappa coefficient | Kappa coefficient≥0.75 indicates high consistency; 0.75>Kappa coefficient≥0.4, considered consistent; If the Kappa coefficient is less than 0.4, it is considered inconsistent. | Through study completion, an average of 1 year |
| The Raman analyzer usability evaluation | Use Evaluation Form | Through study completion, an average of 1 year |
| Time consumption for the Raman analyzer in detecting gliomar | Time required from emitting laser to completing single point detection | Through study completion, an average of 1 year |
Number of subjects with AE/total number of subjects ×100% |
| During the surgery |
| Serious Adverse Event Incidence Rate | Number of subjects with SAE/total number of subjects ×100% | During the surgery |
| Operator adverse events | Possible damage to device operators during the use and maintenance of the Raman analyzers | Through study completion, an average of 1 year |
| The First Affiliated Hospital of Zhengzhou University |
| Principal Investigator |
| Shouwei Li | Capital Medical University | Principal Investigator |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |