UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036142 |
|---|---|
| Receipt number | R000041174 |
| 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. |
| Date of disclosure of the study information | 2019/03/09 |
| Last modified on | 2021/04/05 21:49:54 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
takobayashi-hok@umin.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041174
