UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039884 |
|---|---|
| Receipt number | R000045482 |
| Scientific Title | Establishment of disease registry of primary sclerosing cholangitis for investigation of clinical features, natural history, and prognostic factors; RADDAR-J [13] |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2020/06/01 12:31:54 |
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Basic information
Public title
Disease registry of primary sclerosing cholangitis
Acronym
Disease registry of primary sclerosing cholangitis
Scientific Title
Establishment of disease registry of primary sclerosing cholangitis for investigation of clinical features, natural history, and prognostic factors; RADDAR-J [13]
Scientific Title:Acronym
Disease registry of primary sclerosing cholangitis
Region
| Japan |
Condition
Condition
Primary sclerosing cholangitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
1) We aim to prospectively register clinical information, sera, and DNA of patients with primary sclerosing cholangitis (PSC) in Japan and to establish comprehensive as well as long-standing PSC registry.
Basic objectives2
Others
Basic objectives -Others
2) With the PSC resigtry in Japan, we also aim to clarify clinical characteristics, natural history and prognostic factors of PSC.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Death or liver transplantation
Key secondary outcomes
1) developmenet of cholangiocarcinoma or colorectal cancer
2) develpment of clinical events including bacterial cholangitis, jaundice
3) progression of liver fibrosis
4) EQ-5D-5L
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 who were diagnosed as primary sclerosing cholangitis (definite or probable) with the MHLW criteria
2) Patients who gave informed consent to participate in this study
Key exclusion criteria
1) Patients who were diagnosed as primary sclerosing cholangitis (possible) with the MHLW criteria
2) Patients who were diagnosed as IgG4-related sclerosing cholangitis or secondary sclerosing cholangitis
Target sample size
2300
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Tanaka |
Organization
Teikyo University School of Medicine
Division name
Department of Medicine
Zip code
1738605
Address
2-11-1, Kaga, Itabashi-ku, Tokyo, Japan
TEL
0339641211
a-tanaka@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Kayono |
| Middle name | |
| Last name | Unno |
Organization
Teikyo University School of Medicine
Division name
Department of Medicine
Zip code
1738605
Address
2-11-1, Kaga, Itabashi-ku, Tokyo, Japan
TEL
0339641211
Homepage URL
k-unno@med.teikyou.ac.jp
Sponsor or person
Institute
Teikyo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Health, Labor and Welfare
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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 | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is;
1)To prospectively register patients with PSC
2) To collect clinical information at baseline and every year thereafter
3) To collect DNA of the patients
4) To collect serum and plasma of the patients at baseline and every year thereafter
Management information
Registered date
| 2020 | Year | 03 | Month | 19 | Day |
Last modified on
| 2020 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045482
