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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033887
Receipt No. 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 2018/08/24

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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
Middle name
Last name Yuichi Tsuchiya
Organization Toho University School of Medicne
Division name Division of Biochemistry, Department of Biochemistry
Zip code
Address 5-21-16 Omori-nishi, Ota-ku, Tokyo
TEL 03-3762-4151
Email tsuchiya@med.toho-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuichi Tsuchiya
Organization Toho University School of Medicne
Division name Division of Biochemistry, Department of Biochemistry
Zip code
Address 5-21-16 Omori-nishi, Ota-ku, Tokyo
TEL 03-3762-4151
Homepage URL
Email tsuchiya@med.toho-u.ac.jp

Sponsor
Institute Toho University
Institute
Department

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
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
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
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 Enrolling by invitation
Date of protocol fixation
2018 Year 08 Month 03 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 15 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 08 Month 24 Day
Last modified on
2018 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038652

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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