UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014550 |
|---|---|
| Receipt number | R000016928 |
| Scientific Title | To calculate new biomarkers and its efficacy of the progresion for non-alcoholic fatty liver disease patients. |
| Date of disclosure of the study information | 2014/07/15 |
| Last modified on | 2020/07/20 07:19:19 |
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Basic information
Public title
To calculate new biomarkers and its efficacy of the progresion for non-alcoholic fatty liver disease patients.
Acronym
To calculate new biomarkers and its efficacy of the progresion for non-alcoholic fatty liver disease patients.
Scientific Title
To calculate new biomarkers and its efficacy of the progresion for non-alcoholic fatty liver disease patients.
Scientific Title:Acronym
To calculate new biomarkers and its efficacy of the progresion for non-alcoholic fatty liver disease patients.
Region
| Japan |
Condition
Condition
non-alcoholic fatty liver disease (NAFLD)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To calculate new biomarker with nonivasive methods for NAFLD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Staging of fibrosis and inflammatory with NAFLD liver.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with diagnosed NAFLD
Key exclusion criteria
none
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Michiharu |
| Middle name | |
| Last name | Komatsu |
Organization
Shinshu Univercity of Medicine
Division name
Gastoenterology
Zip code
390-8621
Address
Asahi 3-1-1,Matsumoto, Nagano
TEL
0263-35-4600
komichi@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Michiharu |
| Middle name | |
| Last name | Komatsu |
Organization
Shinshu Univercity of Medicine
Division name
Gastoenterology
Zip code
390-8621
Address
Asahi 3-1-1,Matsumoto, Nagano
TEL
0263-35-4600
Homepage URL
komichi@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University of Medicine
Institute
Department
Personal name
Funding Source
Organization
The hospital of Shinshu University of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics commitee in Shinshu University of medicine
Address
Asahi 3-1-1,Matsumoto, Nagano
Tel
0263-37-2572
mdrinri@shinshu-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
| 2014 | Year | 07 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
preinitiation
Management information
Registered date
| 2014 | Year | 07 | Month | 14 | Day |
Last modified on
| 2020 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016928
