Computer Aided Tool for Diagnosis of Neck Masses in Children

Sponsor
West China Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05187923
Collaborator
(none)
1,500
1
48
31.3

Study Details

Study Description

Brief Summary

The aim of this study was to evaluate the diagnostic efficacy of computer aided diagnostic tool for neck masses using machine learning and deep learning techniques on clinical information and radiological images in children.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Artificial Intelligence Algorithm

Detailed Description

This study is a retrospective-prospective design by West China Hospital, Sichuan University, including clinical data and radiological images. A retrospective database was enrolled for patients with definite histological diagnosis and available radiological images from June 2010 and December 2020. The investigators have constructed deep learning and machine learning diagnostic models on this retrospective cohort and validated it internally. A prospective cohort would recruit patients found neck masses since January 2021. The proposed computer aided diagnostic models would also be validated in this prospective cohort externally. The aim of this study was to evaluate the diagnostic efficacy of computer aided diagnostic tool for neck masses using machine learning and deep learning techniques on clinical data and radiological images in children.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1500 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Computer Aided Tool for Diagnosis of Neck Masses in Children
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Retrospective cohort

The internal cohort was retrospectively enrolled in West China Hospital, Sichuan University from June 2010 and December 2020. It is a training and internal validation cohort.

Diagnostic Test: Artificial Intelligence Algorithm
Different machine learning and deep learning computer aided strategies for model construction and validation.

Prospective cohort

The same inclusion/exclusion criteria were applied for the same center prospectively. It is an external validation cohort.

Diagnostic Test: Artificial Intelligence Algorithm
Different machine learning and deep learning computer aided strategies for model construction and validation.

Outcome Measures

Primary Outcome Measures

  1. The diagnostic accuracy of neck masses with AI-based screening tools in children [1 month]

    The diagnostic accuracy of neck masses with AI-based screening tools in children.

Secondary Outcome Measures

  1. The diagnostic sensitivity of neck masses with AI-based screening tools in children [1 month]

    The diagnostic sensitivity of neck masses with AI-based screening tools in children.

  2. The diagnostic specificity of neck masses with AI-based screening tools in children [1 month]

    The diagnostic specificity of neck masses with AI-based screening tools in children.

  3. The diagnostic positive predictive value of neck masses with AI-based screening tools in children [1 month]

    The diagnostic positive predictive value of neck masses with AI-based screening tools in children.

  4. The diagnostic negative predictive value of neck masses with AI-based screening tools in children [1 month]

    The diagnostic negative predictive value of neck masses with AI-based screening tools in children

Eligibility Criteria

Criteria

Ages Eligible for Study:
0 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age up to 18 years old

  • Receiving no treatment before diagnosis

  • With written informed consent

Exclusion Criteria:
  • Clinical data missing

  • Unavailable radiological images

  • Without written informed consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 West China Hospital, Sichuan University Chengdu Sichuan China 6100041

Sponsors and Collaborators

  • West China Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yuhan Yang, Associate Professor, West China Hospital
ClinicalTrials.gov Identifier:
NCT05187923
Other Study ID Numbers:
  • HX-20211023
First Posted:
Jan 12, 2022
Last Update Posted:
Jan 27, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 27, 2022