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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046101
Receipt No. R000052611
Scientific Title Prediction of clinical relapse by NBI-CAD in patients with ulcerative colitis.
Date of disclosure of the study information 2021/12/01
Last modified on 2021/11/17

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Basic information
Public title Prediction of clinical relapse by NBI-CAD in patients with ulcerative colitis.
Acronym UC relapse prediction by NBI-CAD
Scientific Title Prediction of clinical relapse by NBI-CAD in patients with ulcerative colitis.
Scientific Title:Acronym UC relapse prediction by NBI-CAD
Region
Japan

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

Objectives
Narrative objectives1 NBI-CAD evaluates its usefulness in predicting relapse of ulcerative colitis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes UC-CAD clinical relapse rate by diagnosis(12 month).
Key secondary outcomes

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 with a definite diagnosis of ulcerative colitis in advance
Patients undergoing lower gastrointestinal endoscopy due to clinical need
Clinical remission
Endoscopic remission
Patients who have not used prednisolone within 6 months
Patients with no history of radiation therapy for the abdomen or pelvis
Key exclusion criteria Patients who have been asked to refuse to participate in this study
Patients who could not be followed up at the end of the study or until relapse
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kentaro
Middle name
Last name Mochida
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code 2248503
Address 35-1, Chigasakityuo, Tsuzuki-ku, Yokohama, Japan
TEL 09097786308
Email yappabananamk@yahoo.co.jp

Public contact
Name of contact person
1st name Kentaro
Middle name
Last name Mochida
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code 2248503
Address 35-1, Chigasakityuo, Tsuzuki-ku, Yokohama, Japan
TEL 09097786308
Homepage URL
Email yappabananamk@yahoo.co.jp

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

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Showa University Northern Yokohama Hospital
Address 35-1, Chigasakityuo, Tsuzuki-ku, Yokohama, Japan
Tel 0459497567
Email yappabananamk@yahoo.co.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
2021 Year 12 Month 01 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 Open public recruiting
Date of protocol fixation
2021 Year 06 Month 25 Day
Date of IRB
2021 Year 06 Month 30 Day
Anticipated trial start date
2021 Year 11 Month 17 Day
Last follow-up date
2023 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Evaluate the clinical relapse rate by diagnosis of UC-CAD

Management information
Registered date
2021 Year 11 Month 17 Day
Last modified on
2021 Year 11 Month 17 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052611

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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