UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018715 |
|---|---|
| Receipt number | R000021650 |
| Scientific Title | A strategy screening out risky cases of steatohepatitis at a medical checkup |
| Date of disclosure of the study information | 2015/08/18 |
| Last modified on | 2018/09/08 06:44:15 |
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Basic information
Public title
A strategy screening out risky cases of steatohepatitis at a medical checkup
Acronym
NASH screening
Scientific Title
A strategy screening out risky cases of steatohepatitis at a medical checkup
Scientific Title:Acronym
NASH screening
Region
| Japan |
Condition
Condition
Fatty liver diseases
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
By quantitating liver stiffness at a medical checkup, this study aims to accomplish the followings.
1) Epidemiology of fatty liver diseases
2) Formulate to screen out risky cases of NASH using standard tests at a medical checkup, and validate it
3) Clarify the etiology and risk of progression in NASH based on questionnaires of diet and activity
4) Establish a novel marker in management of NASH
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Establishment of a formula to select risky cases of NASH
Key secondary outcomes
Significance of liver stiffness and a selection formula in NAFLD management
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) Liver stiffness was measured
2) anti-HCV(-), HBsAg(-), no other known etiology for chronic liver disease
3) Informed consent was obtained in a written format
Key exclusion criteria
1) CTR exceeding 50%
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Suda |
Organization
Uonuma Institute of Community Medicine,
Niigata University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
4132 Urasa, Minami-uonuma, Niigata
TEL
025-777-3200
tspitt@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Abe |
Organization
Joetsu Community Health Care Center
Division name
A medical checkup center
Zip code
Address
1-2-33 Kasugano, Joetsu, Niigata
TEL
025-524-7111
Homepage URL
abe@joetsu.niigata.med.or.jp
Sponsor or person
Institute
4132 Urasa, Minami-uonuma, Niigata
Institute
Department
Personal name
Funding Source
Organization
Daiwa Capital Markets
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Division of Gastroenterology and Hepatology,
Graduate School of Medical and Dental Sciences,
Niigata University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
上越地域総合健康管理センター
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 18 | 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
| 2015 | Year | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 17 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Using the residual blood sample, perform various examination including genomic analysis
Management information
Registered date
| 2015 | Year | 08 | Month | 18 | Day |
Last modified on
| 2018 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021650
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
