UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041103 |
|---|---|
| Receipt number | R000046767 |
| Scientific Title | Data collection and clinical epidemiological evaluation based on the construction and management of a registry of ulcerative colitis (UC) |
| Date of disclosure of the study information | 2020/07/14 |
| Last modified on | 2022/07/19 10:21:12 |
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Basic information
Public title
Data collection and clinical epidemiological evaluation based on the construction and management of a registry of ulcerative colitis (UC)
Acronym
Data collection and clinical epidemiological evaluation based on the construction and management of a registry of ulcerative colitis (UC)
Scientific Title
Data collection and clinical epidemiological evaluation based on the construction and management of a registry of ulcerative colitis (UC)
Scientific Title:Acronym
Data collection and clinical epidemiological evaluation based on the construction and management of a registry of ulcerative colitis (UC)
Region
| Japan |
Condition
Condition
ulcerative colitis (UC)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To construct the registry of patients with UC in Japan and observe the treatment pattern, course of disease, and adverse events
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
N/A
Because the purpose of this study is construct registry.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who were 18 years-old or more at the time of informed consent in this study
2. Patients who diagnosed UC based on UC diagnostic criteria according to the treatment guidelines "Research on Intractable Inflammatory Bowel Disease" at the time of informed consent in this study
3. Patients who obtained written informed consent
Key exclusion criteria
Patients who were deemed unsuitable for inclusion in this study by investigators
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Katsuyoshi |
| Middle name | |
| Last name | Matsuoka |
Organization
Toho University Sakura Medical Center
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
285-8741
Address
564-1 Shimoshizu, Sakura, Chiba, Japan
TEL
043-462-8811
matsuoka@fk2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Iwanaga |
| Middle name | |
| Last name | Yusuke |
Organization
Mebix, Inc.
Division name
Division of research promotion
Zip code
541-0046
Address
9F. Aioi Nissay Dowa Insurance Midosuji Building, 3-6-1 Hirano-cho, Chuo-ku, Osaka-shi, Osaka, Japan
TEL
06-6226-0657
Homepage URL
yusuke.iwanaga@mebix.co.jp
Sponsor or person
Institute
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Sakura Medical Center
Institute
Department
Personal name
Funding Source
Organization
Mebix, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Toho University Sakura Medical Center
Address
564-1 Shimoshizu, Sakura, Chiba, Japan
Tel
043-462-8811
sakura.rinri@ext.toho-u.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
北里大学北里研究所病院(東京都）、東京医科歯科大学医学部附属病院（東京都）、旭川医科大学病院（北海道）、九州大学病院（福岡県）、滋賀医科大学医学部附属病院（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 08 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a observational study.
Management information
Registered date
| 2020 | Year | 07 | Month | 14 | Day |
Last modified on
| 2022 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046767
| 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 |
