UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032580 |
|---|---|
| Receipt number | R000037151 |
| Scientific Title | Evaluation of endocyto index using narrow band imaging for predicting relapse of ulcerative colitis |
| Date of disclosure of the study information | 2018/05/14 |
| Last modified on | 2019/03/31 14:17:29 |
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Basic information
Public title
Evaluation of endocyto index using narrow band imaging for predicting relapse of ulcerative colitis
Acronym
Endocyto index for predicting relapse of UC
Scientific Title
Evaluation of endocyto index using narrow band imaging for predicting relapse of ulcerative colitis
Scientific Title:Acronym
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
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The comparison of the rate of relapse in endocyto index.
Key secondary outcomes
The correlation between endocyto index and histologial activity.
The correlation between endocyto index and mayo endoscopic subscore.
The correlation between endocyto index and clinical activity.
The intra and inter-agreement of endocyto index.
Base
Study type
Others,meta-analysis etc
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 of ulcerative colitis with clinical remission stage, who were received colonoscopy with endocyto.
Key exclusion criteria
Patients who did not obtain consent
Target sample size
100
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, Chigasakityuo, Tsuzuki-ku, Yokohama, Japan
TEL
0459497567
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, Chigasakityuo, Tsuzuki-ku, Yokohama, Japan
TEL
0459497567
Homepage URL
yasuharumaeda610@hotmail.com
Sponsor or person
Institute
Digestive Disease Center,Showa University Northern Yokohama Hospital
Institute
Department
Personal name
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
Address
Tel
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
| 2018 | Year | 05 | Month | 14 | 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
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | 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 histological healing.
Management information
Registered date
| 2018 | Year | 05 | Month | 14 | Day |
Last modified on
| 2019 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037151
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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