UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040656 |
|---|---|
| Receipt number | R000046390 |
| Scientific Title | Multicenter registry study of Japanese patients with inflammatory bowel disease with COVID-19 |
| Date of disclosure of the study information | 2020/08/01 |
| Last modified on | 2020/06/04 22:37:48 |
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Basic information
Public title
Multicenter registry study of Japanese patients with inflammatory bowel disease with COVID-19
Acronym
Japan COVID-19 surveillance in inflammatory bowel disease (J-COSMOS)
Scientific Title
Multicenter registry study of Japanese patients with inflammatory bowel disease with COVID-19
Scientific Title:Acronym
Japan COVID-19 surveillance in inflammatory bowel disease (J-COSMOS)
Region
| Japan |
Condition
Condition
inflammatory bowel disease
COVID-19
Classification by specialty
| Gastroenterology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the rate of COVID-19 in Japanese IBD patients.
Basic objectives2
Others
Basic objectives -Others
To invesigate the rate of Japanese IBD patients with COVID-19 and their clinical outcome.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of Japanese IBD patients with COVID-19
Key secondary outcomes
At the diagnosis of SARS-CoV-2 infection and COVID-19, treatment of IBD and the COVID-19 severity.
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
Inflammatory bowel disease patients with COVID-19 infection (ulcerative colitis, Crohn's disease, inflammatory bowel disease unclassified, intestinal Behcet's disease, simple ulcer)
Key exclusion criteria
Those who refused to participate in the study by opr-out
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | HIROSHI |
| Middle name | |
| Last name | NAKASE |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8543
Address
South 1 West 16, Chuo-ku, Sapporo, 060-8543, Japan
TEL
011-611-2111
hiropynakase@gmail.com
Public contact
Name of contact person
| 1st name | DAISUKE |
| Middle name | |
| Last name | HIRAYAMA |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8543
Address
South 1 West 16, Chuo-ku, Sapporo, 060-8543, Japan
TEL
011-611-2111
Homepage URL
hirarin95@yahoo.co.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Health and Labour Sciences Research Grants for research on intractable diseases from the Ministry of Health, Labour and Welfare of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Sapporo Medical University Hospital
Address
South 1 West 16, Chuo-ku, Sapporo, 060-8543, Japan
Tel
011-611-2111
ji-rskk@sapmed.ac.jp
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
札幌医科大学（北海道）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | 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
| 2020 | Year | 06 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Case registration will be made by the participating institutions.
At the moment, the deadline for patient registration is December 31, 2021.
Management information
Registered date
| 2020 | Year | 06 | Month | 04 | Day |
Last modified on
| 2020 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046390
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
