UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036650 |
|---|---|
| Receipt number | R000041751 |
| Scientific Title | Prospective study of clinical relapse prediction of ulcerative colitis using automated diagnosis system with ultra-magnification endoscope |
| Date of disclosure of the study information | 2019/05/07 |
| Last modified on | 2022/05/16 20:25:36 |
* 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
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
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
yasuharumaeda610@hotmail.com
Sponsor or person
Institute
Digestive Disease Center,Showa University Northern Yokohama Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041751
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
