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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04215211
Other study ID # GliomaAI-2
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date June 1, 2027

Study information

Verified date February 2021
Source The First Affiliated Hospital of Zhengzhou University
Contact Zhenyu Zhang, Dr.
Phone +86 17839973727
Email fcczhangzy1@zzu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This registry aims to collect clinical, molecular and radiologic data including detailed survival data, clinical parameters, molecular pathology (1p/19q codeletion, 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 patients' survivals in the frame of molecular pathology or subgroups of gliomas.


Description:

Non-invasive and precise prediction for survivals of glioma patients 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 patients' prognosis in the frame of molecular pathology of gliomas. The creation of a registry for primary glioma with detailed survival data, molecular pathology, radiological data and with sufficient sample size for deep learning (>1000) provides opportunities for personalized prediction of survival of glioma patients with non-invasiveness and precision.


Recruitment information / eligibility

Status Recruiting
Enrollment 2500
Est. completion date June 1, 2027
Est. primary completion date January 1, 2027
Accepts healthy volunteers No
Gender All
Age group 1 Year to 90 Years
Eligibility 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 malfuctions

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Survival prediction for glioma patients
Survival prediction of glioma patients in the frame of molecular pathology by leveraging AI

Locations

Country Name City State
China Department of Neurosurgery, First Affiliated Hospital of Zhengzhou University Zhengzhou Henan

Sponsors (2)

Lead Sponsor Collaborator
The First Affiliated Hospital of Zhengzhou University Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary AUC of survival prediction performance AUC of survival prediction performance=sensitivity+specificity-1 up to 10 years
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