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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025644
Receipt No. R000029493
Scientific Title Examination of glycobiomarker of the liver disease
Date of disclosure of the study information 2017/01/12
Last modified on 2019/07/16

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Basic information
Public title Examination of glycobiomarker of the liver disease
Acronym Examination of glycobiomarker of the liver disease
Scientific Title Examination of glycobiomarker of the liver disease
Scientific Title:Acronym Examination of glycobiomarker of the liver disease
Region
Japan

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

Objectives
Narrative objectives1 usefulness of glycobiomarker as NASH marker
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Glycobiomarkers with significant change in NASH and NAFL
Key secondary outcomes Comparison with pathological findings by NAFLD Activity Score

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 The patient who performs a definitive NAFLD diagnosis by the liver biopsy in the patients that fatty liver was accepted by an examination of abdominal ultrasonic diagnosis
Key exclusion criteria That merges hepatitis B, hepatitis C, cirrhosis, a hepatocellular carcinoma, autoimmune hepatitis, primary biliary cirrhosis
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Koji
Middle name
Last name Ogawa
Organization Hokkaido University Hospital
Division name Department of gastroenterology
Zip code 060-8648
Address kita 14 nishi 5, kitaku, Sapporo city, Hokkaido, Japan
TEL 011-716-1161
Email k-ogawa@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Koji
Middle name
Last name Ogawa
Organization Hokkaido University Hospital
Division name Department of gastroenterology
Zip code 060-8648
Address kita 14 nishi 5, 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 Hospital
Institute
Department

Funding Source
Organization Department of gastroenterology and hepatology, Hokkaido University Hospital
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 Ethics Review Committee, Hokkaido University Hospital
Address kita 14 nishi 5, kitaku, Sapporo city, Hokkaido, Japan
Tel 011-716-1161
Email crjimu@huhp.hokudai.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

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 12 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 No longer recruiting
Date of protocol fixation
2016 Year 09 Month 12 Day
Date of IRB
2016 Year 08 Month 26 Day
Anticipated trial start date
2016 Year 09 Month 12 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 07 Month 31 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information currently in progress

Management information
Registered date
2017 Year 01 Month 12 Day
Last modified on
2019 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029493

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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