UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033887 |
|---|---|
| Receipt number | R000038652 |
| Scientific Title | Identification of novel serum biomarkers enabling differential diagnosis of non-alcoholic fatty liver disease |
| Date of disclosure of the study information | 2018/08/24 |
| Last modified on | 2023/11/13 09:41:11 |
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Basic information
Public title
Identification of novel serum biomarkers enabling differential diagnosis of non-alcoholic fatty liver disease
Acronym
Identification of novel serum biomarkers for NAFLD
Scientific Title
Identification of novel serum biomarkers enabling differential diagnosis of non-alcoholic fatty liver disease
Scientific Title:Acronym
Identification of novel serum biomarkers for NAFLD
Region
| Japan |
Condition
Condition
Non-alcoholic fatty liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will compare the levels of novel serum biomarkers among healthy volunteers, simple steatosis patients, and non-alcoholic steatohepatitis patients to explore their usefulness for differential diagnosis of non-alcoholic fatty liver disease.
Basic objectives2
Others
Basic objectives -Others
We will compare the levels of novel serum biomarkers among healthy volunteers, simple steatosis patients, and non-alcoholic steatohepatitis patients to explore their usefulness for differential diagnosis of non-alcoholic fatty liver disease.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We will quantitate the levels of novel serum biomarkers using the sera from healthy volunteers, simple steatosis patients, and non-alcoholic steatohepatitis patients. The results will be statistically analyzed to explore their usefulness.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Healthy volunteer
Abdominal ultrasound echo:Once
Blood draw:Once
Interventions/Control_2
Simple steatosis patient previously diagnosed by liver biopsy
Blood draw:Once
Interventions/Control_3
Non-alcoholic steatohepatitis patient previosly diagnosed by liver biopsy
Blood draw:Once
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
| 40 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy volunteer
1)Written informed consent is required.
2)Individuals of 40-69 years old.
Patient of non-alcoholic fatty liver disease
1)Written informed consent is required.
Key exclusion criteria
Healthy volunteer
1)Individuals diagnosed as fatty liver by abdominal ultrasound echo.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Tsuchiya |
Organization
Toho University School of Pharmaceutical Sciences
Division name
Department of Biochemistry
Zip code
2748510
Address
2-2-1 Miyama, Funabashi-shi, Chiba
TEL
047-472-9199
tsuchiya@phar.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Tsuchiya |
Organization
Toho University School of Medicne
Division name
Division of Biochemistry, Department of Biochemistry
Zip code
2748510
Address
2-2-1 Miyama, Funabashi-shi, Chiba
TEL
047-472-9199
Homepage URL
tsuchiya@phar.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical committee of Toho Unviersity School of Medicine
Address
5-21-16 Omori-nishi, Ota-ku, Tokyo
Tel
03-3762-4151
med.rinri@ext.toho-u.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
| 2018 | Year | 08 | Month | 24 | 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
27
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
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
The original cilinical trial was once terminated on March 31, 2020. After the modification of study design, the clinical trial was restarted on March 19, 2021.
The reserachers are now developing new original monoclonal antibodies and a new ELISA system to improve the sensitivity.
Management information
Registered date
| 2018 | Year | 08 | Month | 24 | Day |
Last modified on
| 2023 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038652
| Research Plan | |
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| Registered date | File name |
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