UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022870 |
|---|---|
| Receipt number | R000026356 |
| Scientific Title | validation of scoring systems for predicting outcomes of patients with primary biliary cholangitis |
| Date of disclosure of the study information | 2016/06/24 |
| Last modified on | 2019/06/27 14:03:39 |
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Basic information
Public title
validation of scoring systems for predicting outcomes of patients with primary biliary cholangitis
Acronym
scoring systems for predicting outcomes in PBC
Scientific Title
validation of scoring systems for predicting outcomes of patients with primary biliary cholangitis
Scientific Title:Acronym
scoring systems for predicting outcomes in PBC
Region
| Japan |
Condition
Condition
primary biliary cholangitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate whether scoring systems developed in Europe and North America for predicting outcomes of patients with PBC are applicable in Japanese PBC patients
Basic objectives2
Others
Basic objectives -Others
To develop scoring systems for Japanese PBC patients if necessary.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
specificity and sensitivity in predicting outcomes in Japanese PBC patients
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
patients with PBC and 1) observed for at least 2 years, 2) treated with UDCA and/or bezafibrate, and 3) in which outcomes are clearly documented
Key exclusion criteria
PBC patients 1) treated with neither UDCA nor bezafibrate, 2) treated with other drugs, 3) less than 18 years old, 4) having other etiologies for chronic liver diseases
Target sample size
1500
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
173-8605
Address
Tokyo
TEL
03(3964)1211
a-tanaka@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Tanaka |
Organization
Teikyo University School of Medicine
Division name
Department of Medicine
Zip code
1738605
Address
Tokyo
TEL
03(3964)1211
Homepage URL
a-tanaka@med.teikyo-u.ac.jp
Sponsor or person
Institute
Ministry of Health, Labour and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour 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
Teikyo University School of Medicine
Address
Tokyo
Tel
03(3964)7256
turb-office@teikyo-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
| 2016 | Year | 06 | Month | 24 | 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
873
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
| 2016 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical data are obtained from enrolled PBC patients in each participating facility. Using these data validation of scoring systems are performed.
Management information
Registered date
| 2016 | Year | 06 | Month | 24 | Day |
Last modified on
| 2019 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026356
