Molecular Pathology Research Project of Glioma

NCT04924127 | Completed DMC

• 1 other identifier: KY2019-539
• Study Type: observational
• Target: 976
• Locations: 1 country
• Sites: 1

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

Conditions

Glioma, Malignant

Keywords

Molecular pathology

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Discovery cohort

Retrospective frozen tissue and paired peripheral blood samples were obtained from the Huashan Glioma Biobank between October 2010 and August 2018. A total of 753 patients diagnosed with supratentorial diffuse glioma (WHO grade 2-4) aged 18-80 years were selected for the study.

Diagnostic Test: Detection of IDH and TERT mutation

Validation cohort

From January to July 2021, 223 frozen tissue samples were retrieved from the Huashan Glioma Biobank. In addition, 107 frozen tumor samples were used to assess the detection accuracy of the IDH and TERTp mutation rapid test. The accuracy of this qPCR-based rapid test was further confirmed by Sanger and targeted sequencing.

Diagnostic Test: Detection of IDH and TERT mutation

Interventions

Detection of IDH and TERT mutation DIAGNOSTIC_TEST

Detection of IDH and TERT mutation using frozen glioma tissues

Discovery cohort; Validation cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Glioma patient from Huashan Hospital with Informed Consent Form

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jinsong Wu: lead

Study Sites (1)

Huashan Hospital

Shanghai, Jingan District, 200040, China

Location

Related Publications (1)

• Wu J, Wu S, Cao D, Xiong Z, Zhang J, Zou Y, Wu Z, Nie Y, Luo C, Yao Y, Song Y, Jiao Y, Chen H, Ma H, Kang D, Mao Y, Yan H. Rapid diagnosis of adult-type diffuse glioma using a layered scheme. BMC Med. 2025 Jun 2;23(1):325. doi: 10.1186/s12916-025-04124-9.

  PMID: 40457320 DERIVED

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Jin-song Wu, MD & PhD

  Huashan Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: May 23, 2021
• First Posted: June 11, 2021
• Study Start: December 5, 2019
• Primary Completion: June 6, 2021
• Study Completion: December 20, 2021
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)