Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363162
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-04-09
Brief Title:
Evaluate the Effectiveness and Safety of Raman IVD Analyzer in the Molecular Diagnosis of Gliomas During Surgery
Sponsor:
Beijing Tiantan Hospital
Organization:
Beijing Tiantan Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To distinguish various molecular subtypes of gliomas by spectra data obtained from Raman analyzer including IDH mutant 1p19q-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 size02cmlength 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 median25 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
During surgery core tissue samples were taken from subjects The test samples size02cmlength 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 median25 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None