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Clinical Trials/NCT04220424
NCT04220424
Unknown
Not Applicable

Glioma Patients Registry Based on MR Images, Histopathology Images and Genetic Sequencing Analyzed by Artificial Intelligence

The First Affiliated Hospital of Zhengzhou University1 site in 1 country500 target enrollmentNovember 1, 2018
ConditionsGlioma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Glioma
Sponsor
The First Affiliated Hospital of Zhengzhou University
Enrollment
500
Locations
1
Primary Endpoint
AUC of Prediction performance
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2018
End Date
March 1, 2022
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
The First Affiliated Hospital of Zhengzhou University
Responsible Party
Principal Investigator
Principal Investigator

Zhenyu Zhang

Principal Investigator

The First Affiliated Hospital of Zhengzhou University

Eligibility Criteria

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

Outcomes

Primary Outcomes

AUC of Prediction performance

Time Frame: up to 2 years

AUC of Prediction performance=sensitivity+specificity-1

Study Sites (1)

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