UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033004 |
|---|---|
| Receipt number | R000036752 |
| Scientific Title | Investigation on EBV infection status and immunosuppressive treatment in Japanese IBD patients |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2018/06/15 13:17:39 |
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Basic information
Public title
Investigation on EBV infection status and immunosuppressive treatment in Japanese IBD patients
Acronym
EBISU study
Scientific Title
Investigation on EBV infection status and immunosuppressive treatment in Japanese IBD patients
Scientific Title:Acronym
EBISU study
Region
| Japan |
Condition
Condition
inflammatory bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we investigate the EBV antibody titer of patients with IBD including children and clarify the prevalence of EBV infection by age. Then, it compares with the use situation of IBD therapeutic agent, especially thiopurine preparation and biological preparation, and clarifies the actual situation in Japan.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of EBV infection by age in patient with IBD
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
Patient with IBD of all age.
Key exclusion criteria
Patient who can not obtain consent of participation in this study.
Target sample size
510
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadakazu Hisamatsu |
Organization
Kyorin University School of Medicine
Division name
The Third Department of Internal Medicine
Zip code
Address
6-20-2 Shinkawa Mitaka Tokyo
TEL
0422-47-5511
thisamatsu@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miki Miura |
Organization
Kyorin University School of Medicine
Division name
The Third Department of Internal Medicine
Zip code
Address
6-20-2 Shinkawa Mitaka Tokyo
TEL
0422-47-5511
Homepage URL
jasmine.miu.m@gmail.com
Sponsor or person
Institute
Kyorin University School of Medicine
Institute
Department
Personal name
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
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 | 07 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 03 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
As a cross sectional observational study, we will clarify the status of EBV infection by age.
Management information
Registered date
| 2018 | Year | 06 | Month | 15 | Day |
Last modified on
| 2018 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036752
