Development and Validation of a Deep Learning-Based Survival Prediction Model for Pediatric Glioma Patients: A Retrospective Study Using the SEER Database and Chinese Data

December 27, 2023 updated by: Tang-Du Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This retrospective study focuses on survival prediction in pediatric glioma patients using a population-based approach. 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. 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9532

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shannxi
      • Xi'an, Shannxi, China, 710000
        • Tangdu Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability 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

Description

Inclusion Criteria:

  • 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, among patients under 21 years old, and meeting the third edition of the ICD-O-3 classification.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
We recorded clinically relevant information and survival status of pediatric glioma patients
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
We recorded clinically relevant information and survival status of pediatric glioma patients

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 2000.01-2018.12
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
Time Frame: 2010.01-2018.12
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tang-Du Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 16, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TDLL-202312-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data involves the relevant personal privacy information of the patient

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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