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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003686
Receipt No. R000004465
Scientific Title Evaluation of clinical utility of serum choline level as a marker of non-alcoholic steatohepatitis.
Date of disclosure of the study information 2010/06/02
Last modified on 2018/12/07

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Basic information
Public title Evaluation of clinical utility of serum choline level as a marker of non-alcoholic steatohepatitis.
Acronym Evaluation of clinical utility of serum choline level as a marker of non-alcoholic steatohepatitis.
Scientific Title Evaluation of clinical utility of serum choline level as a marker of non-alcoholic steatohepatitis.
Scientific Title:Acronym Evaluation of clinical utility of serum choline level as a marker of non-alcoholic steatohepatitis.
Region
Japan

Condition
Condition Non-alcoholic fatty liver diseases (Simple steatosis of the liver and non-alcoholic steatohepatitis).
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the clinical utility of serum choline level as a marker of non-alcoholic steatohepatitis.
Basic objectives2 Others
Basic objectives -Others Measurement of serum choline level and evaluation of the positive and negative predictive values of non-alcoholic steatohepatitis from patients with simple steatosis of the liver.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation of the association between non-alcoholic steatohepatitis and serum choline level.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with non-alcoholic fatty liver diseases who underwent percutaneous liver biopsy.
Key exclusion criteria None
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Osamu Kozawa
Organization Gifu University Graduate School of Medicine
Division name Department of Pharmacology
Zip code
Address Yanagito 1-1, Gifu, Gifu, Japan 501-1194
TEL 058-230-6214
Email okozawa@gifu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Rie Nishiwaki
Organization Gifu University Graduate School of Medicine
Division name Department of Pharmacology
Zip code
Address Yanagito 1-1, Gifu, Gifu, Japan 501-1194
TEL 058-230-6217
Homepage URL
Email riemn@gifu-u.ac.jp

Sponsor
Institute Department of Pharmacology, Gifu University Graduate School of Medicine
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
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
2010 Year 06 Month 02 Day

Related information
URL releasing protocol
Publication of results Published

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 Terminated
Date of protocol fixation
2010 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information retorospective study

Management information
Registered date
2010 Year 05 Month 31 Day
Last modified on
2018 Year 12 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004465

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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