NCT06199388

Brief Summary

Accurately predicting the survival of pediatric glioma patients is crucial for informed clinical decision-making and selecting appropriate treatment strategies. However, there is a lack of prognostic models specifically tailored for pediatric glioma patients. This study aimed to address this gap by developing a time-dependent deep learning model to aid physicians in making more accurate prognostic assessments and treatment decisions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9,532

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 20, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 27, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
Last Updated

January 10, 2024

Status Verified

December 1, 2023

Enrollment Period

11 months

First QC Date

December 27, 2023

Last Update Submit

December 27, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • overall survival

    The primary outcome was overall survival (OS), which was defined as the time interval from the pediatric glioma diagnosis until death or the end of follow-up in SEER registry

    2000.01-2018.12

  • overall survival

    The primary outcome was overall survival (OS), which was defined as the time interval from the pediatric glioma diagnosis until death or the end of follow-up in Chinese registry

    2010.01-2018.12

Study Arms (2)

SEER database

The model was trained using the Surveillance, Epidemiology, and End Results (SEER) Registry database. To identify specific tumor types, the International Classification of Diseases for Oncology, 3rd Edition codes (ICD-O-3) were used, including codes 9450, 9394, 9421, 9384, 9383, 9424, 9400, 9420, 9410, 9411, 9380, 9382, 9391, 9393, 9390, 9401, 9381, 9451, 9440, 9441, 9442, 9430, and 9380, covering astrocytic tumors, oligodendroglia tumors, oligoastrocytic tumors, ependymal tumors, and other gliomas. Inclusion criteria comprised all primary brain tumors (C71.0-C71.9, C72.3, C72.8, C75.3) diagnosed between 2000 and 2018, among patients under 21 years old, and meeting the third edition of the ICD-O-3 classification. Only patients with available survival time were included, and those with unknown or missing clinical features were excluded.

Other: Survival state

Chinese cohort

To assess the generalizability of the final model, an external validation cohort from China was used. This cohort consisted of 258 pediatric glioma patients diagnosed at Tangdu Hospital in Xi\'an, China, between January 2010 and December 2018. These patients had complete clinical data and comprehensive follow-up records.

Other: Survival state

Interventions

We recorded clinically relevant information and survival status of pediatric glioma patients

Chinese cohortSEER database

Eligibility Criteria

AgeUp to 21 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

the US Surveillance, Epidemiology, and End Results (SEER) between January 2000 and December 2018 and a Chinese registry (The Tangdu Hospital of the Fourth Military Medical Universitye) between January 2010 and December 2018

You may not qualify if:

  • Only patients with available survival time were included, and those with unknown or missing clinical features were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tangdu Hospital

Xi'an, Shannxi, 710000, China

Location

Related Publications (2)

  • Thomas L, Li F, Pencina M. Using Propensity Score Methods to Create Target Populations in Observational Clinical Research. JAMA. 2020 Feb 4;323(5):466-467. doi: 10.1001/jama.2019.21558. No abstract available.

  • Doll KM, Rademaker A, Sosa JA. Practical Guide to Surgical Data Sets: Surveillance, Epidemiology, and End Results (SEER) Database. JAMA Surg. 2018 Jun 1;153(6):588-589. doi: 10.1001/jamasurg.2018.0501. No abstract available.

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

December 27, 2023

First Posted

January 10, 2024

Study Start

September 20, 2022

Primary Completion

August 16, 2023

Study Completion

December 20, 2023

Last Updated

January 10, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

The data involves the relevant personal privacy information of the patient

Locations