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RECRUITING
NCT06363162
NA

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

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2022-12-01

Completion Date

2025-12-31

Last Updated

2024-04-12

Healthy Volunteers

No

Conditions

Interventions

DIAGNOSTIC_TEST

Immunohistochemistry or genetic test

Perform two diagnostic methods on the same sample

Locations (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China