Molecular Pathology Research Project of Glioma

Glioma, Malignant Clinical Trial

Official title:

Exploring the Feasibility of the Molecular Pathology Model of Patients With Glioma Via Retrospective Research

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04924127
• Other study ID #: KY2019-539
• Status: Completed
• Start date: December 5, 2019
• Est. completion date: December 20, 2021

Study information

• Verified date: April 2023
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Evaluate the diagnostic value of TERT promoter mutation in differ glioma subtypes and expend the application of the diagnostic algorithm to surgical practice

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, 1p/19q, TERT, EGFRamp and 7+/10- 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 0.2% and 0.5%, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 976
• Est. completion date: December 20, 2021
• Est. primary completion date: June 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Glioma

• Glioma patient with long-term follow-up data and intact clinical data

Exclusion Criteria:

• Glioma patient without Informed Consent Form

• Glioma patient without long-term follow-up data or intact clinical data

Related Conditions & MeSH terms

• Glioma
• Glioma, Malignant

Intervention

Diagnostic Test:
• Detection of IDH and TERT mutation
Detection of IDH and TERT mutation using frozen glioma tissues

Locations

Country	Name	City	State
China	Huashan Hospital	Shanghai	Jingan District

Sponsors (1)

Lead Sponsor	Collaborator
Jinsong Wu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the diagnostic value of TERT promoter mutation in differ glioma subtypes	According to WHO CNS5, all recommended alteration including IDH, 1p/19q, TERT, EGFRamp and 7+/10- 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	through study completion, an average of 1 week
Primary	Derivation and validation of a simplified diagnostic scheme	Derivation of a simplified diagnostic scheme based on IDH and TERT promoter (TERTp) mutations combined with histology and evaluation of its feasibility of stratifying the prognosis of patients with glioma when comparing with WHO CNS5 criteria.	through study completion, an average of 1 week