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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030720
Receipt No. R000035074
Scientific Title Comprehensive analysis of serum and tissue glycobiomarkers in chronic liver disease
Date of disclosure of the study information 2018/01/07
Last modified on 2019/01/15

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Basic information
Public title Comprehensive analysis of serum and tissue glycobiomarkers in chronic liver disease
Acronym Comprehensive analysis of serum and tissue glycobiomarkers in chronic liver disease
Scientific Title Comprehensive analysis of serum and tissue glycobiomarkers in chronic liver disease
Scientific Title:Acronym Comprehensive analysis of serum and tissue glycobiomarkers in chronic liver disease
Region
Japan

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

Objectives
Narrative objectives1 Identify glycobiomarkers useful for diagnosis and prognosis of chronic liver disease
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Identify glycobiomarkers associated with fibrosis progression of chronic liver disease
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Cases diagnosed as hepatitis B, hepatitis C, NAFLD
Key exclusion criteria co-infection with HBV and HCV, other chronic liver diseases, malignant tumor
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoya Sakamoto
Organization Hokkaido University
Division name Department of gastroenterology and hepatology
Zip code
Address kita 15 nishi 7, kitaku, Sapporo city, Hokkaido, Japan
TEL 011-716-1161
Email sakamoto@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Ogawa
Organization Hokkaido University
Division name Department of gastroenterology and hepatology
Zip code
Address kita 15 nishi 7, kitaku, Sapporo city, Hokkaido, Japan
TEL 011-716-1161
Homepage URL
Email k-ogawa@med.hokudai.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Hokkaido University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2018 Year 01 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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 16 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Currently in progress

Management information
Registered date
2018 Year 01 Month 07 Day
Last modified on
2019 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035074

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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