NCT05624736

Brief Summary

This is a restrospective study to establish a deep learning model based on multi-parametric magnetic resonance imaging scans to predict Grade, histopathologic type and genotype of adult diffuse Glioma.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

November 20, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

November 22, 2022

Status Verified

July 1, 2022

Enrollment Period

5 months

First QC Date

November 13, 2022

Last Update Submit

November 21, 2022

Conditions

Keywords

AstrocytomaGlioblastomaOligodendrogliomadeep learningartificial intelligence

Outcome Measures

Primary Outcomes (3)

  • Tumor Grade

    Tumor Grade based on 2021 WHO central nervous system tumor guideline

    up to 2 weeks

  • Tumor Histologic diagnosis

    Tumor histologic diagnosis based on 2021 WHO central nervous system tumor guideline

    up to 2 weeks

  • Tumor genotype

    Tumor genotype based on 2021 WHO central nervous system tumor guideline

    up to 2 weeks

Study Arms (3)

Glioblastoma Group

Patients with the diagnosis of Glioblastoma based on 2021 WHO central nervous system tumor guideline.

Diagnostic Test: multi-parametric magnetic resonance imaging scanDiagnostic Test: Pathology examination

Astrocytoma Group

Patients with the diagnosis of Astrocytoma based on 2021 WHO central nervous system tumor guideline.

Diagnostic Test: multi-parametric magnetic resonance imaging scanDiagnostic Test: Pathology examination

Oligodendroglioma Group

Patients with the diagnosis of Oligodengroglioma based on 2021 WHO central nervous system tumor guideline.

Diagnostic Test: multi-parametric magnetic resonance imaging scanDiagnostic Test: Pathology examination

Interventions

Pre-operative multi-parametric magnetic resonance imaging scans including T1WI, T2WI, T1CE, FLAIR and DWI were taken for clinical needs.

Astrocytoma GroupGlioblastoma GroupOligodendroglioma Group
Pathology examinationDIAGNOSTIC_TEST

The tumor specimen obtained from the surgery were sent to the pathology department for histopathologic examination, immunohistochemistry and gene sequencing test

Astrocytoma GroupGlioblastoma GroupOligodendroglioma Group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with diagnosis of adult diffuse glioma who recevived tumor rection surgery in our center

You may qualify if:

  • Patients undergoing surgery in Nanjing DrumTower Hospital between 2010.01 and 2022.05 with post-surgery pathological diagnosis of WHO Grade II to IV Adult Diffuse Glioma.
  • Available pre-surgery T1WI, T2WI, T1CE, FLARI and DWI MR sequences
  • No pre-surgery anti-tumor therapy

You may not qualify if:

  • Poor image quality
  • Failed image preprocessing
  • Unavailable pathology data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiology, the Affiliated Drum Tower Hospital of Nanjing University

Nanjing, Jiangsu, 210093, China

RECRUITING

MeSH Terms

Conditions

AstrocytomaGlioblastomaOligodendroglioma

Condition Hierarchy (Ancestors)

GliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Central Study Contacts

Xin Zhang, Master

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2022

First Posted

November 22, 2022

Study Start

November 20, 2022

Primary Completion

May 1, 2023

Study Completion

May 1, 2025

Last Updated

November 22, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

We don't plan to share IPD with other researches

Locations