UMIN-CTR Clinical Trial

Basic information
Public title	Clinical Relapse Prediction of Ulcerative Colitis Using an Endoscopy Automated Diagnosis System
Acronym	Clinical Relapse Prediction of Ulcerative Colitis
Scientific Title	Prospective study of clinical relapse prediction of ulcerative colitis using automated diagnosis system with ultra-magnification endoscope
Scientific Title:Acronym	Prospective study of clinical relapse prediction of ulcerative colitis
Region	Japan

Condition
Condition	ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To prove the usefulness of clinical relapse prediction in patients with ulcerative colitis using computer aided diagnosis system(UC-CAD) with ultra-magnification endoscope.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the difference in clinical relapse rate according to the diagnosis of UC-CAD.
Key secondary outcomes	1. The differences in clinical relapse rate by extent of disease according to the diagnosis according to UC-CAD 2. The differences in clinical relapse rate according to the diagnosis according to endoscopists. 3. Time required to diagnose UC-CAD 4. Cecal success rate 5. Cecal insertion success time

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who have been diagnosed with establised ulcerative colitis.Patients who perform colonoscopy following to their clinical needs. Patients with clinical remission (partial Mayo Score of 0 or 1).Patients not using Prednisolone within half a year.Patients who have not received radiation therapy for the abdominal or pelvis.
Key exclusion criteria	Patients who have been denied participation in this study Patients who could not follow up at the end of the study or until relapse
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Yasuharu Middle name Last name Maeda
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
Zip code	224-8503
Address	Yokohama
TEL	+81459497000
Email	wakamura92@gmail.com

Public contact
Name of contact person	1st name Yasuharu Middle name Last name Maeda
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
Zip code	224-8503
Address	Yokohama
TEL	+81459497000
Homepage URL
Email	yasuharumaeda610@hotmail.com

Sponsor
Institute	Digestive Disease Center,Showa University Northern Yokohama Hospital
Institute
Department

Funding Source
Organization	none
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	Showa University Northern Yokohama Hospital Digestive Disease Center
Address	35-1 Chigasakichuo Tudukiku Yokohama
Tel	+81459497000
Email	irb02syh@ofc.showa-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	昭和大学横浜市北部病院(神奈川県)

Other administrative information
Date of disclosure of the study information	2019 Year 05 Month 07 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	Completed
Date of protocol fixation	2019 Year 04 Month 05 Day
Date of IRB	2020 Year 05 Month 03 Day
Anticipated trial start date	2019 Year 05 Month 08 Day
Last follow-up date	2020 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

We compare and examine the relapse rate according to the diagnosis of the automatic diagnosis system using the super-magnification endoscope. The observation period is 6 months from the final patient recruitment. Diagnosis of UC-CAD of each localization is performed by majority rule. The diagnosis of UC-CAD in each patient is the diagnosis of the most intense localization of inflammation. The definition of clinical relapse is treatment intervention for partial Mayo Score 3 or higher or symptom exacerbation.

Management information
Registered date	2019 Year 05 Month 05 Day
Last modified on	2022 Year 05 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041751