UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018438 |
|---|---|
| Receipt number | R000021349 |
| Scientific Title | A nation-wide survey of sclerosing cholangitis in Japan |
| Date of disclosure of the study information | 2015/07/27 |
| Last modified on | 2018/02/05 13:35:07 |
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Basic information
Public title
A nation-wide survey of sclerosing cholangitis in Japan
Acronym
A nation-wide survey of sclerosing cholangitis in Japan
Scientific Title
A nation-wide survey of sclerosing cholangitis in Japan
Scientific Title:Acronym
A nation-wide survey of sclerosing cholangitis in Japan
Region
| Japan |
Condition
Condition
sclerosing cholangitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To survey general features of primary sclerosing cholangitis and IgG4-related sclerosing cholangitis in Japan
Basic objectives2
Others
Basic objectives -Others
epidemiological study
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of new cases, clinical features, treatment and prognosis of patients with PSC and IgG4-SC in referral centers in Japan
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
Diagnosed as PSC or IgG4-SC
Key exclusion criteria
N/A
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Tanaka |
Organization
Teikyo University School of Medicine
Division name
Dept of Medicine
Zip code
Address
2-11-1,kaga,Itabashi-ku
TEL
03(3964)1211
a-tanaka@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Tanaka |
Organization
Teikyo University School of Medicine
Division name
Dept of Medicine
Zip code
Address
2-11-1,kaga,Itabashi-ku
TEL
03(3964)1211
Homepage URL
a-tanaka@med.teikyo-u.ac.jp
Sponsor or person
Institute
the Intractable Hepato-Biliary Diseases Study Group in Japan
Institute
Department
Personal name
Funding Source
Organization
MHLW
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2015 | Year | 07 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2015 | Year | 05 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
In this study we will collect clinical information of patients with PSC or IgG4-SC in Japan.
Management information
Registered date
| 2015 | Year | 07 | Month | 27 | Day |
Last modified on
| 2018 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021349
