UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046457 |
|---|---|
| Receipt number | R000052802 |
| Scientific Title | Multi-institutional study on the efficacy of computer-aided diagnosis of pancreatic EUS |
| Date of disclosure of the study information | 2022/12/23 |
| Last modified on | 2021/12/23 22:56:56 |
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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
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
tonozuka@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052802
