Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04924127
Status:
COMPLETED
Last Update Posted:
2023-04-19
First Post:
2021-05-23
Brief Title:
Molecular Pathology Research Project of Glioma
Sponsor:
Jinsong Wu
Organization:
Huashan Hospital
Study Overview
Official Title:
Exploring the Feasibility of the Molecular Pathology Model of Patients With Glioma Via Retrospective Research
Status:
COMPLETED
Status Verified Date:
2023-04
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:
Evaluate the diagnostic value of TERT promoter mutation in differ glioma subtypes and expend the application of the diagnostic algorithm to surgical practice
Detailed Description:
A total of 976 gliomas were enrolled in this study First in order to evaluate the diagnostic value of TERT promoter mutation in differ glioma subtypes we conducted a retrospective cohort study included 753 frozen tissue samples of patients with different grades of glioma According to WHO CNS5 all recommended alteration including IDH 1p19q TERT EGFRamp and 710- were profiled using multiple approaches and a permanent diagnosis was obtained for each patient Exploring the feasibility of the molecular pathology model of patients with glioma via retrospective research Compare with the existing molecular pathology system analyze the combination of IDH and TERT mutations and the feasibility of stratifying the prognosis of patients with glioma
Moreover to expend the application of the diagnostic algorithm to surgical practice we developed a fast detection assay that could detect hotspot somatic mutations in IDH and TERT within 25 minutes and can discriminate TERT and IDH mutations from wild-type alleles with a minimum variant allele frequency VAF of 02 and 05 respectively We further validate the simplified diagnostic algorithm on frozen tissue of 223 patients with glioma in another retrospective cohort and performed this assay to evaluate the accuracy of the rapid assay
Moreover to expend the application of the diagnostic algorithm to surgical practice we developed a fast detection assay that could detect hotspot somatic mutations in IDH and TERT within 25 minutes and can discriminate TERT and IDH mutations from wild-type alleles with a minimum variant allele frequency VAF of 02 and 05 respectively We further validate the simplified diagnostic algorithm on frozen tissue of 223 patients with glioma in another retrospective cohort and performed this assay to evaluate the accuracy of the rapid assay
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