UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013046 |
|---|---|
| Receipt number | R000014620 |
| Scientific Title | A diagnosis of fatty liver using controlled attenuation parameter (CAP) loading Fibroscan and a comparative analysis with clinical data |
| Date of disclosure of the study information | 2014/02/02 |
| Last modified on | 2018/06/19 15:55:34 |
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Basic information
Public title
A diagnosis of fatty liver using controlled attenuation parameter (CAP) loading Fibroscan and a comparative analysis with clinical data
Acronym
A utility of quantitative controlled attenuation parameter (CAP) loading Fibroscan to diagnose fatty liver
Scientific Title
A diagnosis of fatty liver using controlled attenuation parameter (CAP) loading Fibroscan and a comparative analysis with clinical data
Scientific Title:Acronym
A utility of quantitative controlled attenuation parameter (CAP) loading Fibroscan to diagnose fatty liver
Region
| Japan |
Condition
Condition
Abnormality of liver function
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy of diagnosis fatty liver using CAP loading Fibroscan as a non-invasive diagnostic tool.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CAP score(the evaluation of liver fat content:Fibroscan)
Key secondary outcomes
Liver stiffness(Fibroscan),physical parameters, blood biochemical values and ultrasound scanning.
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
the patients with an abnormality of liver function who got the informed consent for this study.
Key exclusion criteria
the patient who did not get the informed consent for this study.
Target sample size
530
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Nishizaki |
Organization
Tokai University School of Medicine
Division name
Dept. of Clinical Health Science
Zip code
Address
1-2-5 Yoyogi, Shibuya-ku, Tokyo, JAPAN
TEL
81-3-3370-2321
y-nishizaki@tok.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Kikuchi |
Organization
Tokai University School of Medicine
Division name
Dept. of Gastroenterology
Zip code
Address
1-2-5 Yoyogi, Shibuya-ku, Tokyo, JAPAN
TEL
81-3-3370-2321
Homepage URL
kikuchim490611@yahoo.co.jp
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kagome Co.Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 02 | 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
| 2014 | Year | 01 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 14 | 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
Management information
Registered date
| 2014 | Year | 02 | Month | 02 | Day |
Last modified on
| 2018 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014620
