UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023286 |
|---|---|
| Receipt number | R000026830 |
| Scientific Title | Comparing several biomarkers to predict liver fibrosis in patients with nonalcoholic fatty liver disease |
| Date of disclosure of the study information | 2016/07/23 |
| Last modified on | 2021/06/23 06:24:18 |
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Basic information
Public title
Comparing several biomarkers to predict liver fibrosis in patients with nonalcoholic fatty liver disease
Acronym
Comparing several biomarkers to predict liver fibrosis in patients with nonalcoholic fatty liver disease
Scientific Title
Comparing several biomarkers to predict liver fibrosis in patients with nonalcoholic fatty liver disease
Scientific Title:Acronym
Comparing several biomarkers to predict liver fibrosis in patients with nonalcoholic fatty liver disease
Region
| Japan |
Condition
Condition
nonalcoholic fatty liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate which markers more accurately reflect the fibrosis stage in patients with nonalcoholic fatty liver disease
Basic objectives2
Others
Basic objectives -Others
To evalute the values of sensitivity and specificity for various biomarkers in each fibrosis stage.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The values of AUC, sensitivity, specificity, PPV, and NPV for various biomarkers.
Correlation between serum fibrotic markers for predicting liver fibrosis.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1,Taking alcohol less than 20g/day for female and 30g/day for male respectively
2,patients diagnosed as NAFLD by liver biopsy
Key exclusion criteria
1,alcohol abuse (quantity of ethanol intake more than 20g/day for female and 30g/day for male respectively)
2,type 1 diabetes,
3,positive HBs antigen, HCV antibody, or HIV antibody,
4,other liver diseases, such as autoimmune hepatitis, primary biliary cirrhosis, and drug-induced liver disorder
5,being treated with oral vitamin E preparation and thiazolidinediones for NAFLD or other disorders
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Masanori Atsukawa |
Organization
Nippon Medical School Chiba Hokusoh Hospital
Division name
Division of Gastroenterology
Zip code
270-1196
Address
1715,Kamakari,Inzai,Chiba, 270-1694, Japan
TEL
0476-99-1111
atsukawa-nms@umin.ac.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Atsukawa |
Organization
Nippon Medical School Chiba Hokusoh Hospital
Division name
Division of Gastroenterology
Zip code
2701613
Address
1715,Kamakari,Inzai,Chiba, 270-1694, Japan
TEL
0476-99-1111
Homepage URL
atsukawa-nms@umin.ac.jp
Sponsor or person
Institute
Nippon Medical School Chiba Hokusoh Hospital
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School Chiba Hokusoh Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Center for Global Health and Medicine (NCGM)
Shinmatsudo Central General Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School Chiba Hokousoh Hospital
Address
1715 Kamagari Inzai Chiba
Tel
+81476991111
araraki@nms.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
日本医科大学千葉北総病院（千葉県）Nippon Medical School Chiba Hokusoh Hospital
国立国際医療研究センター（千葉県）National Center for Global Health and Medicine (NCGM)
新松戸中央総合病院（千葉県）Shinmatsudo Central General Hospital (Chiba)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 23 | 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
| 2016 | Year | 06 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Comparison of liver fibrosis biomarkers in patients with NAFLD diagnosed by liver biopsy
Management information
Registered date
| 2016 | Year | 07 | Month | 22 | Day |
Last modified on
| 2021 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026830
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