Glioma Patients Registry Based on Radiological, Histopathological and Genetic Analysis

NCT04220424 | Unknown DMC

• 1 other identifier: GliomaAI-6
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma

Keywords

Artificial intelligence; MR images; histopathology images; sequencing; mechanism

Outcome Measures

Primary Outcomes (1)

• AUC of Prediction performance

  AUC of Prediction performance=sensitivity+specificity-1

  up to 2 years

Interventions

MR and Histopathology images based prediction of molecular pathology and patient survival DIAGNOSTIC_TEST

MR and Histopathology images based prediction of molecular pathology and patient survival in gliomas by leverage artificial intelligence algorithms

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 with preoperative MR images and postoperative histopathology images

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

CONTACT

+86 17839973727; fcczhangzy1@zzu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 4, 2020
• First Posted: January 7, 2020
• Study Start: November 1, 2018
• Primary Completion: January 1, 2022
• Study Completion: March 1, 2022
• Last Updated: February 8, 2021

Record last verified: 2021-02

Locations

CN (1)