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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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To distinguish various molecular subtypes of gliomas by spectra data obtained from Raman analyzer, including IDH mutant, 1p/19q-codeleted, ATRX deletion, TERT promoter mutation, MGMT promoter methylation, EGFR amplification, H3 K27-altered, TP53 mutant, PTEN deficiency, ki 67, AQP4, VEGF, and so on, comparing with the results of Immunohistochemistry or genetic test on the same brain tissue samples.
1500 samples were included retrospectively with the spectra data obtained from Raman analyzer to establish clinical intelligence model, modifying the analyzer. Based on statistical calculations, 200 glioma samples will be included in the trial in all trial centers prospectively. Compare the results between the Raman analyzer and Immunohistochemistry or genetic test results. And calculate the AUC, the accuracy, sensitivity, the specificity, and other indicators of Raman analyzer.
During surgery, core 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 | Experimental | Perform the diagnosis of Raman analyzer and immunohistochemistry or genetic test on the same sample. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunohistochemistry or genetic test | Diagnostic Test | Perform two diagnostic methods on the same sample |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve | The Area Under the Curve of the ROC curve illustrates the performance of Raman analyzer for the diagnosis of molecular subtype in glioma, confirmed by immunohistochemistry or genetic test. | Through study completion, an average of 1 year |
| Accuracy | The proportion of tissue samples with consistent results between Raman analyzer detection and immunohistochemistry or genetic test. | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | Among one kind of molecular subtype samples determined by immunohistochemistry or genetic test, the percentage of samples detected by Raman analyzer as the same molecular subtype. | Through study completion, an average of 1 year |
| Specificity |
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Inclusion Criteria:
Exclusion Criteria:
Investigator judge that it is not suitable for inclusion.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Yinyan, MD and PhD | Contact | +86 13581698953 | tiantanyinyan@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Qing Mao | West China Hospital | Principal Investigator |
| Dongming Yan | The First Affiliated Hospital of Zhengzhou University | Principal Investigator |
| Shouwei Li |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Recruiting | Beijing | Beijing Municipality | 100071 | China |
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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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| ID | Term |
|---|---|
| D007150 | Immunohistochemistry |
| D005820 | Genetic Testing |
| ID | Term |
|---|---|
| D006651 | Histocytochemistry |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| INDUSTRY |
The same sample was diagnosed using Raman spectroscopy and immunohistochemistry or genetic test, respectively. Calculate the AUC, the accuracy, the sensitivity and specificity of a Raman analyzer using immunohistochemistry or genetic test 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 immunohistochemistry or genetic test after surgery are not aware of the subjects' preoperative diagnostic results and the diagnostic results of Raman analyzer.
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Among one kind of molecular subtype samples determined by immunohistochemistry or genetic test, the percentage of samples detected by Raman analyzer as the different molecular subtype. |
| 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 |
| Time consumption for the Raman analyzer in detection | Time required from emitting laser to completing single point detection | Through study completion, an average of 1 year |
| Adverse Event Incidence Rate | 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 |
| Capital Medical University |
| Principal Investigator |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| D005821 | Genetic Techniques |
| D033142 | Genetic Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |