UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002623 |
|---|---|
| Receipt number | R000003196 |
| Scientific Title | Development of non-invasive brief diagnostic marker of nonalcoholic steatohepatitis used by serum free choline score |
| Date of disclosure of the study information | 2009/10/13 |
| Last modified on | 2009/10/13 13:06:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of non-invasive brief diagnostic marker of nonalcoholic steatohepatitis used by serum free choline score
Acronym
Development of diagnostic marker of nonalcoholic steatohepatitis
Scientific Title
Development of non-invasive brief diagnostic marker of nonalcoholic steatohepatitis used by serum free choline score
Scientific Title:Acronym
Development of diagnostic marker of nonalcoholic steatohepatitis
Region
| Japan |
Condition
Condition
nonalcoholic steatohepatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of brief diagnostic marker of NASH
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
efficacy of primary screening marker before liver biopsy
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All of subjects
Key exclusion criteria
none
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Fujita |
Organization
Yokohama-city University Hospital
Division name
gastroenterology
Zip code
Address
3-9, fukuura, kanazawa-ku, yokohama-city
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Yokohama-city University Hospital
Division name
gastroenterology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Yokohama-city university
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2009 | Year | 10 | Month | 13 | 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
| 2009 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients with fatty liver are analyzed serum free choline, and compared prevalence of NASH about high and low score of serum free choline.
Management information
Registered date
| 2009 | Year | 10 | Month | 13 | Day |
Last modified on
| 2009 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003196
