UMIN-CTR Clinical Trial

Basic information
Public title	Cohort study of liver pathogenesis by MR elastography and/or transient elastography in nonalcoholic fatty liver disease
Acronym	Cohort study of liver pathogenesis by MR elastography and/or transient elastography in nonalcoholic fatty liver disease
Scientific Title	Cohort study of liver pathogenesis by MR elastography and/or transient elastography in nonalcoholic fatty liver disease
Scientific Title:Acronym	Cohort study of liver pathogenesis by MR elastography and/or transient elastography in nonalcoholic fatty liver disease
Region	Japan

Condition
Condition	nonalcoholic fatty liver disease
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the time-dependent change of liver pathogenesis by using MR elastography and transient elastgraphy in patients with nonalcoholic fatty liver disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To assess the time-dependent change of liver fibrosis and liver steatosis by using MR elastography and transient elastgraphy in patients with nonalcoholic fatty liver disease.
Key secondary outcomes	To assess the time-dependent change of liver inflammation and liver iron metabolism by using MR elastography and transient elastgraphy in patients with nonalcoholic fatty liver disease. To assess the time-dependent change of hematological examination in patients with nonalcoholic fatty liver disease.

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	1. Patients with suspected NAFLD by interview, blood collection, imaging studies. 2. Patients who are provided a written informed consent, and do not meet the below exclusion criteria.
Key exclusion criteria	1. MRI examination is impossible (ex. Installation of pacemaker, claustrophobia) 2. Pregnant patients 3. In the opinion of the investigator, patient is unsuitable as a study subject.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Yuji Middle name Last name Ogawa
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	236-0004
Address	3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa
TEL	045-787-2640
Email	ogaway@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Yuji Middle name Last name Ogawa
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	236-0004
Address	3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa
TEL	045-787-2640
Homepage URL
Email	ogaway@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Yokohama City University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama City University Graduate School of Medicine
Address	3-9 Fukuura,Kanazawaku, Yokohama
Tel	045-787-2800
Email	ogaway@yokohama-cu.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	横浜市立大学附属病院

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 07 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	Completed
Date of protocol fixation	2016 Year 03 Month 01 Day
Date of IRB	2016 Year 03 Month 08 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2021 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2021 Year 02 Month 28 Day

Other
Other related information	To assess the time-dependent change of liver pathogenesis by using MR elastography and transient elastgraphy.

Management information
Registered date	2016 Year 04 Month 07 Day
Last modified on	2021 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024075