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NCT04216537 Clinical Trial

Survival Significance of Molecular Pathology and Genetic Variation in Brain Gliomas

Glioma Clinical Trial

Official title:
Survival Significance and Clinical Characteristics of Molecular Pathology and Genetic Variation in Brain Gliomas

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04216537
Other study ID # GiomaMG-1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date June 1, 2025

Study information
Verified date February 2021
Source The First Affiliated Hospital of Zhengzhou University
Contact Zhenyu Zhang, Dr.
Phone +86 17839973727
Email fcczhangzy1@zzu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to collect clinical, radiological, pathological, molecular and genetic data including detailed clinical parameters, MR and histopathology images, molecular pathology and genetic data. This study seeks to find the prognostic and clinical significance based on molecular and genetic biomarkers/subgroups of gliomas.

Description:

Precise classification based on molecular and genetic biomarkers/subgroups for gliomas is challenging. This study aims to collect clinical, radiological, pathological, molecular and genetic data including detailed clinical parameters, MR and histopathology images, molecular pathology (1p/19q co-deletion, MGMT methylation, IDH and TERTp mutations, etc) and genetic data (Whole exome sequencing, RNA sequencing, proteomics, etc). This study seeks to find the prognostic and clinical significance based on molecular and genetic biomarkers/subgroups of gliomas.

Recruitment information / eligibility
Status Recruiting
Enrollment 3000
Est. completion date June 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender All
Age group 1 Year to 95 Years
Eligibility Inclusion Criteria: - Patients must have radiologically and histologically confirmed diagnosis of primary glioma - Life expectancy of greater than 3 months - Must receive tumor resection - Must have sufficient fresh frozen tissues for NGS - Signed informed consent Exclusion Criteria: - No gliomas - No sufficient amount of tumor tissues for detection of molecular pathology - Patients who are pregnant or breast feeding - Patients who are suffered from severe systematic malfunctions - Do not have sufficient fresh frozen tissues for NGS

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Glioma groups based on molecular pathology or genetic variation
Patients with newly diagnosed glioma that receive tumor resection

Locations
Country Name City State
China Department of Neurosurgery, First Affiliated Hospital of Zhengzhou University Zhengzhou Henan

Sponsors (1)
Lead Sponsor Collaborator
The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall Survival (OS) The length of time from enrollment until the time of death (OS, overall survival) From enrollment to death of patients. Estimated about 5 years.
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