UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010659 |
|---|---|
| Receipt number | R000012469 |
| Scientific Title | The assessment of surrogate marker for diagnosing nonalcoholic steatohepatitis |
| Date of disclosure of the study information | 2013/05/09 |
| Last modified on | 2019/09/19 10:17:45 |
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Basic information
Public title
The assessment of surrogate marker for diagnosing nonalcoholic steatohepatitis
Acronym
Surrogate marker for diagnosing NASH
Scientific Title
The assessment of surrogate marker for diagnosing nonalcoholic steatohepatitis
Scientific Title:Acronym
Surrogate marker for diagnosing NASH
Region
| Japan |
Condition
Condition
nonalcoholic fatty liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the surrogate marker for diagnosing nonalcoholic steatohepatitis using the blood chemistry analysis and the imaging modalities, and to validate the usefulness of the new surrogate marker for outpatients
Basic objectives2
Others
Basic objectives -Others
usefulness
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Examination of the surrogate marker for diagnosing nonalcoholic steatohepatitis
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Written informed concent is required.
2) more than 20 years-old
Key exclusion criteria
1) consumption of more than 20 g/day of alcohol
2) testing positive for HBs-Ag
3) demonstrating evidence of liver disease other than viral hepatitis, such as autoimmune hepatitis or primary biliary cirrhosis
4) no evidence of decompensated liver cirrhosis
5) pregnant and nursing woman
Target sample size
720
Research contact person
Name of lead principal investigator
| 1st name | Teruki |
| Middle name | |
| Last name | Teruki |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Gastroenterology and Metabology
Zip code
7910295
Address
Toon City, Ehime, Japan
TEL
0899605308
teruki-ygc@umin.ac.jp
Public contact
Name of contact person
| 1st name | Teruki |
| Middle name | |
| Last name | Teruki Miyake |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Gastroenterology and Metabology
Zip code
7910295
Address
Shitsukawa, Toon city, Ehime
TEL
0899605308
Homepage URL
teruki-ygc@umin.ac.jp
Sponsor or person
Institute
Ehime University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Ehime University Hospital
Address
Toon Ehime
Tel
+81899605308
teruki-ygc@umin.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
| 2013 | Year | 05 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 12 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective study
examination of surrogate marker for diagnosing nonalcoholic steatohepatitis
Management information
Registered date
| 2013 | Year | 05 | Month | 07 | Day |
Last modified on
| 2019 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012469
