UMIN-CTR Clinical Trial

Basic information
Public title	Diagnostic accuracy of novel scoring systems using serum biomarkers for nonalcoholic steatohepatitis (NASH)
Acronym	Diagnosis of nonalcoholic steatohepatitis by serum biomarkers
Scientific Title	Diagnostic accuracy of novel scoring systems using serum biomarkers for nonalcoholic steatohepatitis (NASH)
Scientific Title:Acronym	Diagnosis of nonalcoholic steatohepatitis by serum biomarkers
Region	Japan

Condition
Condition	Nonalcoholic fatty liver disease (NAFLD)
Classification by specialty	Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate diagnostic accuracy of the scoring systems for fibrotic NASH in NAFLD patients in comparison to the standard diagnosis by liver biopsy.
Basic objectives2	Others
Basic objectives -Others	Diagnostic accuracy
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Area Under the Receiver Operating Characteristic (AUROC) of the scoring systems against the standard method (histopathological diagnosis) in the diagnosis of fibrotic NASH.
Key secondary outcomes	Area Under the Receiver Operating Characteristic (AUROC) of ELF panel score against the standard method (histopathological diagnosis) in the diagnosis of fibrotic NASH.

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	1) Patients who have received a diagnosis of NAFLD (at the time of liver biopsy and blood sampling) 2) Patients who got liver biopsy for the diagnosis of NASH from April 2013 to April 2015 and whose liver biopsy sample has been stored 3) Patients whose serum sample was collected within 3 month before or after the liver biopsy and have been stored at or under -80 degrees Celsius 4) Patients whose liver biopsy sample is equal to or longer than 1.5 cm (if the needle size was 16 gauge or bigger) or is equal to or longer than 2.0 cm (if the needle size was 17 or 18 gauge) 5) Patients who are 20 or over 20 years old on the day of signing informed consent. In the case that the informed consent was not required according to the applicable ethical guidelines (Part 12 1 (2) A (b) of "Ethical Guidelines for Medical and Health Research Involving Human Subjects"), the patient must be 20 or over 20 years old when the information of the study is made public. 6) Patients who voluntarily agree to participate in the study by providing written informed consent. However, this may not be applicable if the requirements mentioned in Part 12 1 (2) A (b) of "Ethical Guidelines for Medical and Health Research Involving Human Subjects" are satisfied.
Key exclusion criteria	1) Patients whose alcohol consumption in the preceding year of the liver biopsy were more than 210g/week (30g/day) for men or 140g/week (20g/day) for women (at the time of liver biopsy and blood sampling) 2) Patients who have the following result(s) of immunological test (at the time of liver biopsy and blood sampling) -Hepatitis B (HBs antigen >=0.05U/ml) -Hepatitis C (HCV RNA positive) -Patients who are autoimmune hepatitis (titer of antinuclear antibodies is equal to or more than 80 fold and IgG is equal to or more than 2g/dL, or autoimmune hepatitis diagnosed by histopathology) -Patients who are primary biliary cirrhosis 3) Patients who are suspected another chronic liver disease (at the time of liver biopsy and blood sampling) (e.g., primary sclerosing cholangitis, hemochromatosis, alpha1-antitrypsin deficiency, Wilson's disease, drug-induced hepatic impairment (including fatty liver induced by adrenocortical steroid)) 4) Patients who have history of hepatic, biliary or pancreatic malignant tumor 5) Patients who have liver decompensation such as hepatic encephalopathy, abdominal dropsy,jaundice, variceal hemorrhage, serum bilirubin level more than 2 times of the upper limit of normal (at the time of liver biopsy and blood sampling) 6) Patients whose preserved serum sample repeated freeze-thaw cycles more than six times 7) Patients whose preserved serum sample(s) and/or liver specimen are unsuitable for the diagnosis of NASH in the opinion of the investigator. 8) In the opinion of the investigator, patient are unsuitable as a study subject
Target sample size	400

Research contact person
Last name of lead principal investigator	1st name Middle name Last name (1)Takeshi Okanoue (2)Hiromitsu Kumada
Organization	(1)Saiseikai Suita Hospital (2)Toranomon Hospital Kajigaya
Division name	(1)Honorary Director (2)Director General
Zip code
Address	(1)1-2.Kawazono-cho Suita-shi Osaka-fu JAPAN (2)1-3-1.Kajigaya.Takatsu-ku Kawasaki-shi Kanagawa-ken JAPAN
TEL	(1)06-6382-1521(2)044-877-5111
Email	okanoue@suita.saiseikai.or.jp

Public contact
1st name of contact person	1st name Middle name Last name Fumiyuki Iida
Organization	Sogo Rinsho Medefi Co.,Ltd.
Division name	Business promotion department
Zip code
Address	9F KDX Shinjuku Building 3-2-7 Nishi Shinjuku Shinjuku-ku Tokyo-to JAPAN
TEL	03-6901-6079
Homepage URL
Email	nafld@sogo-medefi.jp

Sponsor
Institute	Saiseikai Suita Hospital
Institute
Department

Funding Source
Organization	Sumitomo Dainippon Pharma Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	大阪府済生会吹田病院(大阪府）

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 02 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	Completed
Date of protocol fixation	2015 Year 04 Month 23 Day
Date of IRB	2015 Year 04 Month 23 Day
Anticipated trial start date	2015 Year 07 Month 21 Day
Last follow-up date	2016 Year 11 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Daignosis of nonalcoholic steatohepatitis by serum biomarkers

Management information
Registered date	2015 Year 07 Month 02 Day
Last modified on	2019 Year 05 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021010