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Trial Title:
Evaluate the Effectiveness and Safety of Raman IVD Analyzer in the Molecular Diagnosis of Gliomas During Surgery
NCT ID:
NCT06363162
Condition:
Glioma
Conditions: Official terms:
Glioma
Conditions: Keywords:
Molecular subtype
Raman
intraoperative
surgery
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
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.
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Masking description:
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.
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Immunohistochemistry or genetic test
Description:
Perform two diagnostic methods on the same sample
Arm group label:
Perform two different tests on the same sample
Other name:
Raman analyzer diagnosis
Summary:
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.
Detailed description:
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients who plan to undergo brain lesion tissue resection surgery or have
preoperative clinical diagnosis of gliomas and plan to undergo biopsy;
- Patients with clinical diagnosis of initial solitary gliomas, or initial solitary
intracranial masses or initial non occupying lesions that do not exclude gliomas
(such as intracranial metastatic lesions, intracranial infectious lesions,
intracranial demyelinating lesions, central nervous system lymphoma, etc.), who have
not received radiotherapy or chemotherapy in the past based on their medical
history;
- The patient or their guardian can understand the research purpose, demonstrate
sufficient compliance with the trial protocol, consent for immunohistochemistry or
genetic test, and sign an informed consent form;
- It is possible to obtain tissue samples with a length diameter greater than 0.2cm.
Patients diagnosed with initial solitary glioma should take core or marginal tissue,
while patients diagnosed with initial single intracranial mass or initial non mass
lesions but maybe with gliomas should be taken core tissue.
Exclusion Criteria:
Investigator judge that it is not suitable for inclusion.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Tiantan Hospital
Address:
City:
Beijing
Zip:
100071
Country:
China
Status:
Recruiting
Contact:
Last name:
Yinyan Wang, MD and PhD
Phone:
+86 13581698953
Email:
tiantanyinyan@126.com
Start date:
December 1, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Beijing Tiantan Hospital
Agency class:
Other
Collaborator:
Agency:
West China Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Zhengzhou University
Agency class:
Other
Collaborator:
Agency:
Capital Medical University
Agency class:
Other
Collaborator:
Agency:
Jiangsu Raman Medical Equipment Co., Ltd.
Agency class:
Industry
Source:
Beijing Tiantan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06363162
