UMIN-CTR Clinical Trial

Basic information
Public title	Study of liver fibrosis diagnosis, comparison of ELF score and/or collagen neo-epitope with various liver fibrosis markers, ultrasound-based elastography, and magnetic resonance elastography.
Acronym	Study of liver fibrosis diagnosis, comparison of ELF score and/or collagen neo-epitope with various liver fibrosis markers, ultrasound-based elastography, and magnetic resonance elastography.
Scientific Title	Study of liver fibrosis diagnosis, comparison of ELF score and/or collagen neo-epitope with various liver fibrosis markers, ultrasound-based elastography, and magnetic resonance elastography.
Scientific Title:Acronym	Study of liver fibrosis diagnosis, comparison of ELF score and/or collagen neo-epitope with various liver fibrosis markers, ultrasound-based elastography, and magnetic resonance elastography.
Region	Japan

Condition
Condition	Patients with chronic liver diseases
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	For liver fibrosis diagnosis, comparison of ELF score and/or collagen neo-epitope with various liver fibrosis markers and image diagnosis (ultrasound-based elastography, magnetic resonance elastography) are conducted.
Basic objectives2	Others
Basic objectives -Others	Comparison of ELF score and collagen-neo epitope with various liver fibrosis markers (type IV collagen 7S, M2BPGi, autotaxin, hyaluronic acid) and various scoring systems (Fib-4, NAFLD fibrosis score)
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of ELF score and/or collagen neo-epitope with liver stiffness measured by magnetic resonance elastography and/or ultrasound-based elastography
Key secondary outcomes	1. Comparison of ELF score and collagen-neo epitope with various liver fibrosis markers (type IV collagen 7S, M2BPGi, autotaxin, hyaluronic acid) and various scoring systems (Fib-4, NAFLD fibrosis score) 2. Analysis of factors related to ELF scores 3. Comparison of ELF score and/or collagen neo-epitope with liver fibrosis stage diagnosed by liver biopsy 4. Utility as liver fibrosis biomarker by follow-up of ELF score and/or collagen neo-epitope over time

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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Patients with diagnosed chronic liver disease (chronic hepatitis B, chronic hepatitis C, nonalcoholic fatty liver disease, alcoholic liver disease, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis) by interview, blood collection, imaging studies. 2. Patients who are provided a written informed consent.
Key exclusion criteria	Patients judged inappropriate by doctor
Target sample size	740

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Kobayashi
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	236-0004
Address	3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa
TEL	0457872640
Email	takobayashi-hok@umin.ac.jp

Public contact
Name of contact person	1st name Takashi Middle name Last name Kobayashi
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	236-0004
Address	3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa
TEL	0457872640
Homepage URL
Email	takobayashi-hok@umin.ac.jp

Sponsor
Institute	Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Yokohama City University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama City University Graduate School of Medicine
Address	3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa
Tel	045-787-2800
Email	takobayashi-hok@umin.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	横浜市立大学附属病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2019 Year 03 Month 09 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	Open public recruiting
Date of protocol fixation	2019 Year 01 Month 09 Day
Date of IRB	2019 Year 04 Month 01 Day
Anticipated trial start date	2019 Year 04 Month 01 Day
Last follow-up date	2028 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To assess the time-dependent change of liver pathogenesis by using ELF score and/or collagen neo-epitope.

Management information
Registered date	2019 Year 03 Month 09 Day
Last modified on	2021 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041174