UMIN-CTR Clinical Trial

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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