UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033753 |
|---|---|
| Receipt number | 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 | 2022/05/16 20:29:49 |
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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
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
yasuharumaeda610@hotmail.com
Sponsor or person
Institute
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
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
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
Terminated
Date of protocol fixation
| 2018 | Year | 08 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 14 | Day |
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
| 2022 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038503
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
