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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041103
Receipt No. 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 2020/07/14

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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
Email 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
Email yusuke.iwanaga@mebix.co.jp

Sponsor
Institute Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Sakura Medical Center
Institute
Department

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
Email 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

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 Preinitiation
Date of protocol fixation
2019 Year 08 Month 14 Day
Date of IRB
Anticipated trial start date
2020 Year 10 Month 01 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
2020 Year 07 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046767

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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