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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023558
Receipt No. R000027089
Scientific Title Evaluation of ulcerative colitis mukcosa using Linked color imaging LCI: single center prospective diagnostic study
Date of disclosure of the study information 2016/08/09
Last modified on 2016/08/09

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Basic information
Public title Evaluation of ulcerative colitis mukcosa using Linked color imaging LCI: single center prospective diagnostic study
Acronym Evaluation of ulcerative colitis mucosa Linked color imaging LCI
Scientific Title Evaluation of ulcerative colitis mukcosa using Linked color imaging LCI: single center prospective diagnostic study
Scientific Title:Acronym Evaluation of ulcerative colitis mucosa Linked color imaging LCI
Region
Japan

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

Objectives
Narrative objectives1 Efficacy
Basic objectives2 Others
Basic objectives -Others Diagnosability
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1 Comparison of concordance rate with Mayo endoscopic sub score using WLI and LCI
2 Comparison of concordance rate with Reddening grade using WLI and LCI
Key secondary outcomes 1 Comparison of diagnosis with Mayo endoscopic sub score and biopsy using WLI and LCI
2 Comparison of Reddening grade with Mayo endoscopic sub score and biopsy using WLI and LCI

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
20 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria Patients who has inclusion criteria as follows
1 Ulcerative colitis patient
2 Remission and mild activity
Key exclusion criteria 1 carcinoma
2 acute abdomen
3 severe inflammation
4 pregnant woman
5 poor general condition patients who has risk for performing endoscopy such as ileus perforation of intestine pancreatitis respiratory disorder heart failure acquired hemophilia intestinal stricture large ulcer large tumor
6 ongoing anti coagulation therapy or anti platelet therapy
7 intolerance of polyethylene glycol only for transanal approach
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumihito Hirai
Organization Fukuoka University Chikushi Hospital
Division name Department of Gastroenterology
Zip code
Address 1-1-1 Zokumyoin Chikushino Fukuoka
TEL 092-921-1011
Email syokaki@fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazutomo Yamasaki
Organization Fukuoka University Chikushi Hospital
Division name Department of Gastroenterology
Zip code
Address 1-1-1 Zokumyoin Chikushino Fukuoka
TEL 092-921-1011
Homepage URL
Email syokaki@fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University Chikushi 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
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 福岡大学筑紫病院(福岡県)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 09 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
2016 Year 03 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is prspective and observational study to check evaluation of ulcerative colitis mucosa using Linked color imaging LCI.

Management information
Registered date
2016 Year 08 Month 09 Day
Last modified on
2016 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027089

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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