UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025644 |
|---|---|
| Receipt number | R000029493 |
| Scientific Title | Examination of glycobiomarker of the liver disease |
| Date of disclosure of the study information | 2017/01/12 |
| Last modified on | 2020/01/23 11:03:42 |
* 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
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
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
k-ogawa@med.hokudai.ac.jp
Sponsor or person
Institute
Department of gastroenterology and hepatology, Hokkaido University Hospital
Institute
Department
Personal name
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
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
Main results already published
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
Publication of results
Management information
Registered date
| 2017 | Year | 01 | Month | 12 | Day |
Last modified on
| 2020 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029493
