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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030234
Receipt No. R000034535
Scientific Title Clinical usefulness of serum Mac-2 binding protein glycosylation isomer in decompensated cirrhosis
Date of disclosure of the study information 2017/12/03
Last modified on 2018/05/26

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Basic information
Public title Clinical usefulness of serum Mac-2 binding protein glycosylation isomer in decompensated cirrhosis
Acronym Serum M2BPGi in decompensated cirrhosis
Scientific Title Clinical usefulness of serum Mac-2 binding protein glycosylation isomer in decompensated cirrhosis
Scientific Title:Acronym 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
1st name
Middle name
Last name Haruki Uojima
Organization Kitasato University school of medicine
Division name Department of Gastroenterology
Zip code
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
1st name
Middle name
Last name Haruki Uojima
Organization Kitasato University school of medicine
Division name Department of Gastroenterology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2017 Year 10 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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