UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049858 |
|---|---|
| Receipt number | R000056791 |
| Scientific Title | Disease Activity in Patients with Ulcerative Colitis (UC) Using Ultra-Magnification Endoscopic Artificial Intelligence (AI)-Assisted Diagnosis |
| Date of disclosure of the study information | 2023/02/21 |
| Last modified on | 2022/12/21 17:56:25 |
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Basic information
Public title
Can AI predict the prognosis of ulcerative colitis?
Acronym
UCAI
Scientific Title
Disease Activity in Patients with Ulcerative Colitis (UC) Using Ultra-Magnification Endoscopic Artificial Intelligence (AI)-Assisted Diagnosis
Scientific Title:Acronym
Disease activity evaluation of UC using AI
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Validation of 2-year relapse rates with ultra magnified endoscopic AI-assisted diagnosis in patients with MES1
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Two-Year Relapse Rates with Ultra Magnified Endoscopy AI-Assisted Diagnosis in Patients with MES1
Key secondary outcomes
Discrimination of Pathological Scores by AI-Assisted Diagnosis in MES1
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with Ulcerative Colitis (UC) attending the Institute of Gastroenterology, Tokyo Women's Medical University, who will undergo colonoscopy
Patients with Mayo Endoscopic Score (MES) 0 or 1 by colonoscopy
Key exclusion criteria
Patients with clinical activity requiring therapeutic intervention at the time of examination (partial Mayo score (PMS) over 2 and rectal bleeding subscore over 1)
Patients deemed ineligible for the study by the principal investigator
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Teppei |
| Middle name | |
| Last name | Omori |
Organization
Tokyo Women`s Medical University
Division name
Institute of Gastroenterology
Zip code
162-8666
Address
8-1, Kawada-cho, Shinjyuku-ku, Tokyo
TEL
+81-3353-8111
omori.teppei@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Teppei |
| Middle name | |
| Last name | Omori |
Organization
Tokyo Women`s Medical University
Division name
Institute of Gastroenterology
Zip code
162-8666
Address
8-1, Kawada-cho, Shinjyuku-ku, Tokyo
TEL
+81-3353-8111
Homepage URL
omori.teppei@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's 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 Women's Medical University
Address
8-1, Kawada-cho, Shinjyuku-ku, Tokyo
Tel
+81-3353-8111
omori.teppei@twmu.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 | 02 | Month | 21 | 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
| 2022 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2022 | Year | 12 | Month | 21 | Day |
Last modified on
| 2022 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056791
