UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029074 |
|---|---|
| Receipt number | R000033255 |
| Scientific Title | The mortality of chronic liver diseases including viral hepatitis and non alcoholic liver disease in Kyoto north area |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2021/03/23 22:29:29 |
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Basic information
Public title
The mortality of chronic liver diseases including viral hepatitis and non alcoholic liver disease in Kyoto north area
Acronym
The mortality of chronic liver disease
Scientific Title
The mortality of chronic liver diseases including viral hepatitis and non alcoholic liver disease in Kyoto north area
Scientific Title:Acronym
The mortality of chronic liver disease
Region
| Japan |
Condition
Condition
Chronic liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to find out the prevalence and the risk of HCC, liver failure, the event of cardiovascular events in the patients with chronic liver disease.
Basic objectives2
Others
Basic objectives -Others
The aims is to assess the mortality of chronic liver diseases.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The prevalence of the liver disease related events; HCC, esophagus varices, liver failure. and the cardiovascular events during 10 years observation period.
Key secondary outcomes
Overall survival, the direct cause of death, the rate of haepato-carcinogenesis, the rate of SVR and reccurance of HCV, the stage of liver fibrosis, the IHC of LOX-1, aSMA, TGFb in the liver tissues, the concentration of serum sLOX-1.
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
Chronic liver disease patients going to North Medical Center of Kyoto prefectural university of medicine.
Key exclusion criteria
No exclusion criteria
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ishiba |
Organization
Kyoto prefectural university of medicine
Division name
Gastroenterology
Zip code
602-8566
Address
Kamigyoku kawaramatichitori hirokojiagaru kajiicho 465, Kyoto, Japan
TEL
0752515519
chiroinu@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ishiba |
Organization
Kyoto prefectural university of medicine
Division name
Gastroenterology
Zip code
602-8566
Address
Kamigyoku kawaramatichitori hirokojiagaru kajiicho 465, Kyoto, Japan
TEL
0752515519
Homepage URL
chiroinu@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto prefectural university of medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto prefectural university of medicine
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto prefectural university of medicine IRB
Address
Kamigyoku kawaramatichitori hirokojiagaru kajiicho 465, Kyoto, Japan
Tel
0752515519
rinri@koto.kpu-m.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
| 2017 | Year | 12 | 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
| 2017 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
under trial
Management information
Registered date
| 2017 | Year | 09 | Month | 10 | Day |
Last modified on
| 2021 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033255
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
