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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036650
Receipt No. 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 2019/05/05

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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 Preinitiation
Date of protocol fixation
2019 Year 04 Month 05 Day
Date of IRB
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
2019 Year 05 Month 05 Day


Link to view the page
URL(English) https://upload.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


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