UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018158 |
|---|---|
| Receipt number | R000021010 |
| Scientific Title | Diagnostic accuracy of novel scoring systems using serum biomarkers for nonalcoholic steatohepatitis (NASH) |
| Date of disclosure of the study information | 2015/07/02 |
| Last modified on | 2019/05/08 09:03:24 |
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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
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
okanoue@suita.saiseikai.or.jp
Public contact
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
nafld@sogo-medefi.jp
Sponsor or person
Institute
Saiseikai Suita Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021010
