Clinical trial NCT06363162: Evaluate the Effectiveness and Safety of Raman IVD Analyzer in the Molecular Diagnosis of Gliomas During Surgery
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glioma
Keywords: Molecular subtype
Raman
intraoperative
surgery
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: West China Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Capital Medical University
name: Jiangsu Raman Medical Equipment Co., Ltd.
First posted: 2024-04-12
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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

Brief 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\<length diameter ≤ 2cm. The sample testing result is based on the Raman test points. Then take the same tissue sample for Immunohistochemistry or genetic test.

Statistical description of all data, including baseline data, all efficacy indicators, and all safety data. The measurement data give the mean, standard deviation, minimum, maximum, median,25 quantile and 75 quantile; Provide frequency and composition ratio for counting data. The baseline data was analyzed using the Full Analysis Set (FAS); The effectiveness analysis adopts FAS and PPS; The security analysis uses the Security Dataset (SS).

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.

Primary outcomes:
measure: Area Under the Curve
timeFrame: Through study completion, an average of 1 year
measure: Accuracy
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Sensitivity
timeFrame: Through study completion, an average of 1 year
measure: Specificity
timeFrame: Through study completion, an average of 1 year
measure: Kappa coefficient
timeFrame: Through study completion, an average of 1 year
measure: Time consumption for the Raman analyzer in detection
timeFrame: Through study completion, an average of 1 year
measure: Adverse Event Incidence Rate
timeFrame: During the surgery
measure: Serious Adverse Event Incidence Rate
timeFrame: During the surgery
measure: Operator adverse events
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: West China Hospital
name: Qing Mao
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Dongming Yan
role: PRINCIPAL_INVESTIGATOR
affiliation: Capital Medical University
name: Shouwei Li
role: PRINCIPAL_INVESTIGATOR
References: