Glioma Patients Registry Based on Radiological, Histopathological and Genetic Analysis

• Conditions: Glioma

• Registration Number: NCT04220424
• Lead Sponsor: The First Affiliated Hospital of Zhengzhou University

Brief Summary

This prospective study aims to collect clinical, radiological, pathological, molecular and genetic data including detailed clinical parameters, MR and histopathology images, molecular pathology and genetic sequencing data. By leveraging artificial intelligence, this registry seeks to construct and refine algorithms that able to predict molecular pathology or clinical outcomes of glioma patients based on MR images and histopathology images, as well as revealing related mechanisms from genetic perspective.

Detailed Description

Non-invasive and precise prediction for molecular biomarkers such as 1p/19q co-deletion, MGMT methylation, IDH and TERTp mutations, and patients survival is challenging for gliomas. With the development of artificial intelligence, much more potential lies in the preoperative conventional/advanced MR imaging (T1 weighted imaging, T2 weighted imaging, FLAIR, contrast-enhanced T1 weighted imaging, diffusion-weighted imaging, and perfusion imaging), and in the histopathology images of HE slices of gliomas could be excavated to aid prediction of molecular pathology and patients' survival of gliomas. 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), and seeks to construct and refine algorithms that able to predict molecular pathology or clinical outcomes of glioma patients based on MR images and histopathology images, as well as revealing related mechanisms from genetic perspective.

Study Timeline

• Study Start: 2018-11-01
• Study First Submitted: 2020-01-04
• Study First Submitted QC: 2020-01-04
• Study First Posted: 2020-01-07
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-05
• Last Update Posted: 2021-02-08
• Primary Completion: 2022-01-01
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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 frozen tissues and peripheral blood samples for sequencing
• Must have high-quality MR images and histopathology images
• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AUC of Prediction performance	up to 2 years	AUC of Prediction performance=sensitivity+specificity-1

Trial Locations

Locations (1)

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