UMIN-CTR Clinical Trial

Basic information
Public title	Multi-institutional prospective study on the efficacy of computer-aided diagnosis (CAD) for ultrasound endoscopic imaging of pancreatic diseases
Acronym	MeCAD
Scientific Title	Multi-institutional study on the efficacy of computer-aided diagnosis of pancreatic EUS
Scientific Title:Acronym	MeCAD
Region	Japan

Condition
Condition	Pancreatic disorders
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Constructing a computer-aided diagnosis model of EUS images of the pancreas using deep learning, one of the methods of AI.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Diagnostic performance of the EUS-CAD model [Receiver Operating Characteristic (ROC) curve, Area under the curve (AUC), sensitivity, specificity, positive predictive value, positive predictive value, negative predictive value)
Key secondary outcomes	(1) Comparison of diagnostic performance in each disease category (2) Univariate and multivariate analysis of factors related to the diagnosis of EUS-CAD model

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who underwent or had undergone EUS as deemed necessary for the treatment of gastrointestinal diseases at the research submitting institution during the study period.
Key exclusion criteria	(1) Patients whose imaging data are deemed to be inappropriate for analysis (2) Patients who have requested not to participate in the study
Target sample size	1620

Research contact person
Name of lead principal investigator	1st name Ryosuke Middle name Last name Tonozuka
Organization	Tokyo Medical University
Division name	Gastroenterology and Hepatology
Zip code	160-0023
Address	Nishishinjuku 6-7-1, Shinjuku-ku Tokyo Japan
TEL	03-3342-6111
Email	tonozuka@tokyo-med.ac.jp

Public contact
Name of contact person	1st name Ryosuke Middle name Last name Tonozuka
Organization	Tokyo Medical University
Division name	Gastroenterology and Hepatology
Zip code	160-0023
Address	Nishishinjuku 6-7-1, Shinjuku-ku Tokyo Japan
TEL	03-3342-6111
Homepage URL
Email	tonozuka@tokyo-med.ac.jp

Sponsor
Institute	Tokyo Medical University
Institute
Department

Funding Source
Organization	Tokyo Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Medical University Institutional Review Board
Address	Nishishinjuku 6-7-1, Shinjuku-ku Tokyo Japan
Tel	03-3342-6111
Email	IRB@tokyo-med.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 12 Month 23 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2021 Year 09 Month 14 Day
Date of IRB	2021 Year 11 Month 12 Day
Anticipated trial start date	2021 Year 12 Month 23 Day
Last follow-up date	2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This research is a study on the feasibility of computer-aided diagnosis using artificial intelligence for EUS images of the pancreas. Video and still image data from endoscopic ultrasound (EUS) performed at the research-sharing facilities listed in 1)-6) below as necessary in daily medical care will be obtained from electronic medical records, and the images will be analyzed using computers at Olympus Medical Systems Corporation, the research-sharing facility, under anonymized conditions. The results of the analysis are then sent back to Tokyo Medical University Hospital, the principal research facility, for evaluation and review by the contributing researchers. Informed consent will be obtained in writing from all eligible patients before or after the EUS examination. 1) Department of Gastroenterology, Tokyo Medical University Hospital, 2) Department of Gastroenterology, International Medical Center, Saitama Medical School, 3) Department of Gastroenterology, Kitasato University Hospital, 4) Department of Gastroenterology, Teinaken-Keijinkai Hospital, 5) Department of Gastroenterology, Dokkyo Medical University Hospital, 6) Third Department of Internal Medicine, Faculty of Medicine, University of Toyama

Management information
Registered date	2021 Year 12 Month 23 Day
Last modified on	2021 Year 12 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052802