UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical usefulness of serum Mac-2 binding protein glycosylation isomer in decompensated cirrhosis
Title of the study (Brief title)	Serum M2BPGi in decompensated cirrhosis
Region	Japan

Condition
Condition	liver cirrhosis
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate usefulness of serum M2BPGi as a novel biomarker for decompensated cirrhosis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of serum M2BPGi level between decompensated cirrhosis and compensated cirrhosis
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	serum M2BPGi
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Liver cirrhosis based on laboratory results and imaging tests
Key exclusion criteria	Cases regarded by doctors as inappropriate for the enrollment for some reasons
Target sample size	500

Research contact person
Name of lead principal investigator	Haruki Uojima
Organization	Kitasato University school of medicine
Division name	Department of Gastroenterology
Address	1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL	+81-42-778-8111
Email	kiruha@kitasato-u.ac.jp

Public contact
Name of contact person	Haruki Uojima
Organization	Kitasato University school of medicine
Division name	Department of Gastroenterology
Address	1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL	+81-42-778-8111
Homepage URL
Email	kiruha@kitasato-u.ac.jp

Sponsor
Institute	Kitasato University School of Medicine
Institute
Department

Funding Source
Organization	Kitasato University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
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	2017 Year 12 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 01 Day
Anticipated trial start date	2017 Year 12 Month 03 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

Management information
Registered date	2017 Year 12 Month 03 Day
Last modified on	2018 Year 05 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034535