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Clinical Trials/NCT04217018
NCT04217018RecruitingNot Applicable

MR Based Prediction of Molecular Biomarkers or Subgroups in Primary Glioma Using Deep Learning or Machine Learning

The First Affiliated Hospital of Zhengzhou University1 site in 1 country3,000 target enrollmentStarted: January 1, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
3,000
Locations
1
Primary Endpoint
AUC of prediction performance

Study Overview

Brief Summary

This registry aims to collect clinical, molecular and radiologic data including detailed clinical parameters, molecular pathology (1p/19q co-deletion, MGMT methylation, IDH and TERTp mutations, etc) and conventional/advanced/new MR sequences (T1, T1c, T2, FLAIR, ADC, DTI, PWI, etc) of patients with primary gliomas. By leveraging artificial intelligence, this registry will seek to construct and refine algorithms that able to predict molecular pathology or subgroups of gliomas.

Detailed Description

Non-invasive and precise prediction for molecular biomarkers such as 1p/19q co-deletion, MGMT methylation, IDH and TERTp mutations is challenging. 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) could be excavated to aid prediction of molecular pathology of gliomas. The creation of a registry for primary glioma with detailed molecular pathology, radiological data and with sufficient sample size for deep learning (>1000) provide considerable opportunities for personalized prediction of molecular pathology with non-invasiveness and precision.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Eligibility Criteria

Ages
1 Year to 95 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Patients must have radiologically and histologically confirmed diagnosis of primary glioma
  • Life expectancy of greater than 3 months
  • Must receive tumor resection
  • Signed informed consent

Exclusion Criteria

  • No gliomas
  • No sufficient amount of tumor tissues for detection of molecular pathology
  • Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic devices
  • 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 10 years

AUC=sensitivity+specificity-1

Secondary Outcomes

No secondary outcomes reported

Investigators

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

Zhenyu Zhang

Principal Investigator

The First Affiliated Hospital of Zhengzhou University

Study Sites (1)

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