Glioma Patients Registry Based on Radiological, Histopathological and Genetic Analysis

February 5, 2021 updated by: Zhenyu Zhang, The First Affiliated Hospital of Zhengzhou University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • Department of Neurosurgery, First Affiliated Hospital of Zhengzhou University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 95 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with newly diagnosed glioma that receive tumor resection with preoperative MR images and postoperative histopathology images

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC of Prediction performance
Time Frame: up to 2 years
AUC of Prediction performance=sensitivity+specificity-1
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Zhengzhou University

Collaborators

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

January 4, 2020

First Submitted That Met QC Criteria

January 4, 2020

First Posted (Actual)

January 7, 2020

Study Record Updates

Last Update Posted (Actual)

February 8, 2021

Last Update Submitted That Met QC Criteria

February 5, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GliomaAI-6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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