UMIN-CTR Clinical Trial

Basic information
Public title	A prospective observational study in patients with chronic liver disease by magnetic resonance elastography
Acronym	A prospective observational study in patients with chronic liver disease by magnetic resonance elastography
Scientific Title	A prospective observational study in patients with chronic liver disease by magnetic resonance elastography
Scientific Title:Acronym	A prospective observational study in patients with chronic liver disease by magnetic resonance elastography
Region	Japan

Condition
Condition	Chronic liver disease
Classification by specialty	Medicine in general Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Association between liver stiffness by magnetic resonance elastography and mortality and the incidence of complications (liver failure, hepatocellular carcinoma, cardiovascular disease, or other malignancies)
Basic objectives2	Others
Basic objectives -Others	Outcome investigation
Trial characteristics_1	Others
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	mortality and the incidence of complications (liver failure, hepatocellular carcinoma, cardiovascular disease, or other malignancies)
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with chronic liver disease who measure MRE.
Key exclusion criteria	Contraindications to MRI measurements
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Masayuki Middle name Last name Kurosaki
Organization	Musashino Red Cross Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	180-8610
Address	1-26-1 Kyonancho Musashinoshi Tokyo 180-8610 Japan
TEL	+81-422-32-3111
Email	kurosaki@musashino.jrc.or.jp

Public contact
Name of contact person	1st name Nobuharu Middle name Last name Tamaki
Organization	Musashino Red Cross Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	180-8610
Address	1-26-1 Kyonancho Musashinoshi Tokyo 180-8610 Japan
TEL	+81-422-32-3111
Homepage URL
Email	nobuharu.tamaki@gmail.com

Sponsor
Institute	Musashino Red Cross Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Musashino red cross hospital Clinical research ethics review committee
Address	1-26-1 Kyonancho Musashinoshi Tokyo 180-8610 Japan
Tel	+81-422-32-3111
Email	kenkyu@musashino.jrc.or.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	武蔵野赤十字病院（東京都）、名寄市立総合病院（北海道）、岩手医科大学病院（岩手県）、横浜市立大学医学部付属病院（神奈川県）、東京医科大学病院（東京都）、大垣市民病院（岐阜県）

Other administrative information
Date of disclosure of the study information	2021 Year 09 Month 01 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	2021 Year 06 Month 28 Day
Date of IRB	2021 Year 08 Month 20 Day
Anticipated trial start date	2021 Year 06 Month 28 Day
Last follow-up date	2030 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Follow-up data from the UMIN000038604 trial will also be integrated.

Management information
Registered date	2021 Year 08 Month 24 Day
Last modified on	2022 Year 02 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051677