UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A diagnosis of fatty liver using controlled attenuation parameter (CAP) loading Fibroscan and a comparative analysis with clinical data
Title of the study (Brief title)	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	Yasuhiro Nishizaki
Organization	Tokai University School of Medicine
Division name	Dept. of Clinical Health Science
Address	1-2-5 Yoyogi, Shibuya-ku, Tokyo, JAPAN
TEL	81-3-3370-2321
Email	y-nishizaki@tok.u-tokai.ac.jp

Public contact
Name of contact person	Masahiro Kikuchi
Organization	Tokai University School of Medicine
Division name	Dept. of Gastroenterology
Address	1-2-5 Yoyogi, Shibuya-ku, Tokyo, JAPAN
TEL	81-3-3370-2321
Homepage URL
Email	kikuchim490611@yahoo.co.jp

Sponsor
Institute	Tokai University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 01 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014620