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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033753
Receipt No. R000038503
Scientific Title The prospective study of endocyto index using narrow band imaging for predicting relapse of ulcerative colitis
Date of disclosure of the study information 2018/08/15
Last modified on 2019/05/05

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Basic information
Public title The prospective study of endocyto index using narrow band imaging for predicting relapse of ulcerative colitis
Acronym The prospective study of endocyto index for predicting relapse of UC
Scientific Title The prospective study of endocyto index using narrow band imaging for predicting relapse of ulcerative colitis
Scientific Title:Acronym The prospective study of endocyto index for predicting relapse of UC
Region
Japan

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

Objectives
Narrative objectives1 The aim of the present study is to evaluateendocyto index for predicting Clinical outcome of UC.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Correlation with EC-index and relapse rate in one year

Key secondary outcomes 1.Predictability of clinical relapse of EC-index in MES0
2.Diagnostic ability of histological inflammatory activity of EC-index
3.Diagnostic ability of histological activity of EC-index by localization
4.Ability to diagnose the histological activity of EC-index in MES0
5.Correlation of EC-index with CRP
6.Correlation of EC-index with ESR


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
15 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients confirmed to be ulcerative colitis beforehand.
Patients who undergo lower gastrointestinal endoscopy according to clinical need.
Patients with clinical remission (partial Mayo Score 0 or 1).
Key exclusion criteria Patients with radiotherapy for abdomen or pelvis.
Patients whose tissue biopsy is impossible (such as chronic blood disease or anticoagulant continuing oral administration).
Patient with MES 2 or 3.
Patients who were requested to refuse participation in this study.
Target sample size 126

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuharu Maeda
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code
Address 35-1 Chigasakichuo Tuduki-ku yokohama kanagawa
TEL +81459497000
Email yasuharumaeda610@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yasuharu Maeda
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code
Address 35-1 Chigasakichuo Tuduki-ku yokohama kanagawa
TEL +81459497000
Homepage URL
Email yasuharumaeda610@hotmail.com

Sponsor
Institute Showa University Northern Yokohama Hospital
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor Showa University Northern Yokohama Hospital Digestive Disease Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 08 Month 15 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
2018 Year 08 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 15 Day
Last follow-up date
2020 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is to evaluate endocyto index for predicting relapse rate of ulcerative colitis with remission.

Management information
Registered date
2018 Year 08 Month 14 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=R000038503

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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