RecruitingNot ApplicableNCT06363162

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

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)

Sponsor

Beijing Tiantan Hospital

Enrollment

200 participants

Start Date

Dec 1, 2022

Study Type

INTERVENTIONAL

Conditions

Glioma

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.

Eligibility

Plain Language Summary

Simplified for easier understanding

This study tests whether a new Raman spectroscopy device — a tool that uses light to analyze tissue — can accurately detect and classify brain tumors (especially gliomas) in real time during surgery or biopsy, compared to standard laboratory pathology. **You may be eligible if...** - You are scheduled for brain surgery or biopsy for a suspected brain tumor - You have not had radiotherapy or chemotherapy before this surgery - You are able to give informed consent (or your guardian can) **You may NOT be eligible if...** - You have already received radiation or chemotherapy for a brain condition - You have other serious health conditions that make participation unsafe - You (or your guardian) are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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