Computer Aided Diagnostic Tool on Computed Tomography Images for Diagnosis of Retroperitoneal Tumor in Children

Sponsor
West China Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05179850
Collaborator
(none)
400
1
35.9
11.1

Study Details

Study Description

Brief Summary

The aim of this study was to evaluate the diagnostic efficacy of computer aided diagnostic tool for retroperitoneal tumor using machine learning and deep learning techniques on computed tomography images in children.

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

Detailed Description

The retroperitoneal space extends from the lumbar region to the pelvic region and houses vital structures such as the kidney, the ureter, the adrenal glands, the pancreas, the aorta and its branches, the inferior vena cava and its tributaries, lymph nodes, and loose connective tissue meshwork along with fat. This space thus allows the silent growth of primary and metastatic tumors, such that clinical features appear often too late. The therapeutic regimen differs on various types of retroperitoneal tumor in children. It is damaging for pediatric patients to acquire histological specimens through invasive procedures. Hence, an urgent evaluation is absolutely necessary for preoperative diagnosis in such cases via noninvasive approaches. 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 computed tomography images from June 2010 and December 2020. The investigators have constructed deep learning and machine learning radiomics diagnostic models on this retrospective cohort and validated it internally. A prospective cohort would recruit infantile patients diagnosed as retroperitoneal tumor since January 2021. The proposed deep learning model 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 retroperitoneal tumor using machine learning and deep learning techniques on computed tomography images in children.

Study Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Computer Aided Diagnostic Tool on Computed Tomography Images for Diagnosis of Retroperitoneal Tumor in Children
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

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: Radiomic Algorithm
Different radiomic, machine learning, and deep learning strategies for radiomic features extraction, sorting features and model constriction.

Prospective cohort

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

Diagnostic Test: Radiomic Algorithm
Different radiomic, machine learning, and deep learning strategies for radiomic features extraction, sorting features and model constriction.

Outcome Measures

Primary Outcome Measures

  1. Pathological tumor diagnosis [Baseline]

    The diagnosis is defined by histopathological specimens from surgery and/or biopsy.

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 computed tomography 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:
NCT05179850
Other Study ID Numbers:
  • HX-2021477
First Posted:
Jan 5, 2022
Last Update Posted:
Jan 20, 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 20, 2022