UMIN-CTR Clinical Trial

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

Nonalcoholic fatty liver disease (NAFLD)

Classification by specialty

Medicine in general	Gastroenterology	Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Saiseikai Suita Hospital

Institute

Department

Personal name

Organization

Sumitomo Dainippon Pharma Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大阪府済生会吹田病院(大阪府）

Date of disclosure of the study information

2015

Year

07

Month

02

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Daignosis of nonalcoholic steatohepatitis by serum biomarkers

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