UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054285 |
|---|---|
| Receipt number | R000061996 |
| Scientific Title | Prospective Cohort Study of Collection and Validation of Clinical Data for the Development of AI Diagnosing Subepithelial Lesions of the Gastrointestinal Tract |
| Date of disclosure of the study information | 2024/04/30 |
| Last modified on | 2024/04/30 07:58:06 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective Cohort Study of the Development of AI Diagnosing Subepithelial Lesions of the Gastrointestinal Tract
Acronym
Development of SEL-AI
Scientific Title
Prospective Cohort Study of Collection and Validation of Clinical Data for the Development of AI Diagnosing Subepithelial Lesions of the Gastrointestinal Tract
Scientific Title:Acronym
Development of SEL-AI
Region
| Japan |
Condition
Condition
Cases undergoing EUS examination aimed at diagnosis, tissue sampling, and follow-up for suspected submucosal tumors of the gastrointestinal tract
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Acquiring training data, researching and developing AI to differentiate gastrointestinal submucosal tumors in EUS images across multiple institutions prospectively, and evaluating its utility."
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Accuracy in SEL's three-category differentiation (GIST, leiomyoma, and others) in EUS by an AI diagnostic system
Key secondary outcomes
Diagnostic performances (sensitivity, specificity, positive predictive value, negative predictive value, accuracy) of an AI diagnostic system and expert physicians in the two-category differentiation (GIST, others) of SEL; diagnostic performances in multi-category classification (accuracy, sensitivity per category); diagnostic capabilities of non-expert physicians; diagnostic capabilities of various biopsy procedures; and EUS findings contributing 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
Cases undergoing upper gastrointestinal EUS examination aimed at precise inspection, tissue sampling, and follow-up for lesions suspected of SEL, with the age of consent being 18 years or older at the time of consent
Key exclusion criteria
Patients deemed unsuitable as research subjects by the principal investigator; patients lacking the capacity to consent
Target sample size
720
Research contact person
Name of lead principal investigator
| 1st name | Kawashima |
| Middle name | |
| Last name | Hiroki |
Organization
Nagoya Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8580
Address
65, Tsuruma-cho, Nagoya, Japan
TEL
052-744-2172
kuwa_tak@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Kuwahara |
| Middle name | |
| Last name | Takamichi |
Organization
Nagoya Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8580
Address
65, Tsuruma-cho, Nagoya, Japan
TEL
052-744-2172
Homepage URL
kuwa_tak@aichi-cc.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University
Address
65, Tsuruma-cho, Nagoya, Japan
Tel
052-744-2172
kuwa_tak@aichi-cc.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
| 2024 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
collection of EUS videos of SEL
Management information
Registered date
| 2024 | Year | 04 | Month | 30 | Day |
Last modified on
| 2024 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061996
