UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039131 |
|---|---|
| Receipt number | R000044629 |
| Scientific Title | Features in Japanese Patients with Inflammatory Bowel Diseases : A multicenter prospective long observational study |
| Date of disclosure of the study information | 2020/01/11 |
| Last modified on | 2020/01/17 13:31:27 |
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Basic information
Public title
Features in Japanese Patients with Inflammatory Bowel Diseases : A multicenter prospective long observational study
Acronym
Far East 1000
Scientific Title
Features in Japanese Patients with Inflammatory Bowel Diseases : A multicenter prospective long observational study
Scientific Title:Acronym
Far East 1000
Region
| Japan |
Condition
Condition
Inflammatory Bowel Disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the disease status, medications, and complications of IBD, which has been rapidly increasing in Japan in recent years, over a long period of time.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. History of medication and incidence of relapse in IBD patients.
2. Incidence of complications in IBD patients.
3. Changes in age of onset of IBD patients.
4. Complication rate of PSC in IBD patients and usefulness of surveillance in MRCP.
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
1. Patients with inflammatory bowel disease
2. Patients of any age
3. Patients who agree to participate this study after receiving an explanation and providing consent forms
Key exclusion criteria
1. Patients who refused to participate in this study
2. Patients judged to be ineligible by the research director
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Kato |
Organization
Chiba University Hospital
Division name
Gastoroenterology
Zip code
2600856
Address
1-8-1, Inohana, Chuo-ku, Chiba city, Chiba prefecture, Japan
TEL
043-222-7171
kato.naoya@chiba-u.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Ohta |
Organization
Chiba University Hospital
Division name
Gastoroenterology
Zip code
2600856
Address
1-8-1, Inohana, Chuo-ku, Chiba city, Chiba prefecture, Japan
TEL
043-222-7171
Homepage URL
ohta.yuki@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
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
Research ethics committee of the graduate school of medicine, Chiba university
Address
1-8-1, Inohana, Chuo-ku, Chiba city, Chiba prefecture, Japan
Tel
043-226-2841
igaku-rinri@office.chiba-u.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 | 01 | Month | 11 | 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
| 2018 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1st data fixation on 30th September 2019.
Management information
Registered date
| 2020 | Year | 01 | Month | 11 | Day |
Last modified on
| 2020 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044629
