Survival Significance of Molecular Pathology and Genetic Variation in Brain Gliomas

Recruiting

• Conditions: Molecular Sequence Variation; Genetic Change; Glioma

• Registration Number: NCT04216537
• Lead Sponsor: The First Affiliated Hospital of Zhengzhou University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2019-12-31
• Study First Submitted QC: 2019-12-31
• Study First Posted: 2020-01-02
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-05
• Last Update Posted: 2021-02-08
• Primary Completion: 2025-01-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	From enrollment to death of patients. Estimated about 5 years.	The length of time from enrollment until the time of death (OS, overall survival)

Trial Locations

Locations (1)

Department of Neurosurgery, First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China