UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050718 |
|---|---|
| Receipt number | R000057783 |
| Scientific Title | Acquisition of clinical data and investigation for the development of artificial intelligence (AI) in the diagnosis of subepithelial lesion -prospective cohort study- |
| Date of disclosure of the study information | 2023/06/30 |
| Last modified on | 2023/03/30 06:14:11 |
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Basic information
Public title
Acquisition of clinical data and investigation for the development of artificial intelligence (AI) in the diagnosis of subepithelial lesion -prospective cohort study-
Acronym
Development study of subepithelial lesion (SEL) - artificial intelligence (AI)
Scientific Title
Acquisition of clinical data and investigation for the development of artificial intelligence (AI) in the diagnosis of subepithelial lesion -prospective cohort study-
Scientific Title:Acronym
Development study of subepithelial lesion (SEL) - artificial intelligence (AI)
Region
| Japan |
Condition
Condition
Suspected upper gastrointestinal subepithelial lesion
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To acquire training data to develop an AI to differentiate subepithelial lesions on ultrasound endoscopic images prospectively at multiple institutions, and to research and develop the AI at the University to investigate its efficacy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy in the three categories of SEL differentiation (GIST, leiomyoma, other SELs) on EUS videos in the AI diagnostic system and expert endoscopists
Key secondary outcomes
Diagnostic performance (sensitivity, specificity, positive predictive value, negative predictive value, accuracy) of the AI diagnostic system and expert endoscopists in the two SEL categories (GIST, others)
Diagnostic performance in multi-category classification (accuracy, sensitivity per category)
Diagnostic performance of non-expert endoscopists, diagnostic performance of various tissue biopsies, and EUS findings that contribute to diagnosis
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients undergoing upper gastrointestinal EUS examination for the purpose of detailed examination, tissue sampling, and follow-up for suspected SEL lesions
(2) Age at the time of consent acquisition is 18 years or older.
(3) Patients who have given their voluntary written consent after receiving sufficient explanation about participating in this study, and with sufficient understanding.
Key exclusion criteria
(1) Patients who are judged by the principal investigator to be inappropriate as research subjects
(2) Patients who are incapable of consent
Target sample size
720
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Kawashima |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8560
Address
65 Tsurumai, Showa-ku, Nagoya,Aichi
TEL
0527412172
h-kawa@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Hirai |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8550
Address
65 Tsurumai, Showa-ku, Nagoya,Aichi
TEL
0527412172
Homepage URL
hiraik53@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya 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
Clinical Review Fairness Section, Management Planning Division, Nagoya University School of Medicine
Address
65 Tsurumai, Showa-ku, Nagoya, Aichi
Tel
0527442479
iga-shinsa@adm.nagoya-u.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
| 2023 | Year | 06 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter prospective cohort study
Target number of cases: Once the study data has reached the target number of cases and two years have elapsed since the start date of data collection, the study will move on to the collection of validation data. The validation data collection period will be 6 months. If the target number of cases is not reached, the enrollment period will be postponed.
1. Study data: 540 cases
2. Validation data: 180 cases
Evaluate the accuracy in the three categories of SEL differentiation (GIST, leiomyoma, and other SELs) on EUS videos in the AI diagnostic system and expert endoscopists.
Management information
Registered date
| 2023 | Year | 03 | Month | 30 | Day |
Last modified on
| 2023 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057783
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
