Histopathology Images Based Prediction of Molecular Pathology in Glioma Using Artificial Intelligence

NCT04217044 | Recruiting

• 1 other identifier: GliomaAI-3
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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 images of HE slices in primary gliomas. By leveraging artificial intelligence, this registry will seek to construct and refine histopathology image based algorithms that are able to predict molecular pathology or subgroups of gliomas.

Conditions

Glioma

Keywords

Molecular; Histopathology image; Deep Learning; Machine Learning

Outcome Measures

Primary Outcomes (1)

• AUC of prediction performance

  AUC=sensitivity+specificity-1

  up to 10 years

Interventions

Histopathology images based prediction of molecular pathology DIAGNOSTIC_TEST

Histopathology images based prediction of 1p/19q co-deletion, MGMT methylation, IDH and TERTp mutations or molecular subgroups by leveraging AI

Eligibility Criteria

• Age: 1 Year - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with newly diagnosed glioma that receive tumor resection

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead
• Sun Yat-sen University: collaborator

Study Sites (1)

Department of Neurosurgery, First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

All participants have signed the informed consent. Fresh frozen tissues of participants are collected immediately after tumor resection and preserved in liquid nitrogen. Whole exome sequencing, RNA sequencing and proteomics are planed to be conducted.

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Zhenyu Zhang, Dr.

CONTACT

+86 17839973727; fcczhangzy1@zzu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 120 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 3, 2020
• Study Start: January 1, 2017
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 8, 2021

Record last verified: 2021-02

Locations

CN (1)