Evaluate the Effectiveness and Safety of Raman IVD Analyzer in the Molecular Diagnosis of Gliomas During Surgery

Glioma Clinical Trial

Official title:

Evaluate the Effectiveness and Safety of the Raman IVD Analyzer in the Molecular Diagnosis of Gliomas During Surgery, Using Samples From Brain Resection Tissue (Ambispective, Multicenter, Blind Evaluation, Single Group Target Value Method)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06363162
• Other study ID #: LRR202404
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Beijing Tiantan Hospital
• Contact: Wang Yinyan, MD and PhD
• Phone: +86 13581698953
• Email: tiantanyinyan[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Glioma

Intervention

Diagnostic Test:
• Immunohistochemistry or genetic test
Perform two diagnostic methods on the same sample

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (5)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	Capital Medical University, Jiangsu Raman Medical Equipment Co., Ltd., The First Affiliated Hospital of Zhengzhou University, West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	Specificity	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
Secondary	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
Secondary	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
Secondary	Adverse Event Incidence Rate	Number of subjects with AE/total number of subjects ×100%	During the surgery
Secondary	Serious Adverse Event Incidence Rate	Number of subjects with SAE/total number of subjects ×100%	During the surgery
Secondary	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