UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046497 |
|---|---|
| Receipt number | R000053055 |
| Scientific Title | Multicenter, retrospective observational study on prognosis and risk of liver fibrosis in patients with nonalcoholic fatty liver disease |
| Date of disclosure of the study information | 2021/12/28 |
| Last modified on | 2023/05/19 06:16:51 |
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Basic information
Public title
The study on prognosis in patients with fatty liver
Acronym
The prognostic study in fatty liver
Scientific Title
Multicenter, retrospective observational study on prognosis and risk of liver fibrosis in patients with nonalcoholic fatty liver disease
Scientific Title:Acronym
The prognostic study in nonalcoholic fatty liver disease
Region
| Japan |
Condition
Condition
Non-alcoholic fatty liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We investigate the factors involved in the progression of liver fibrosis and long-term prognosis in patients with NASH.
Basic objectives2
Others
Basic objectives -Others
Identification of factors associated with long-term prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mortality and its association with patient factors
Key secondary outcomes
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
Patients diagnosed with nonalcoholic fatty liver disease
Key exclusion criteria
1) Patients who have been diagnosed with infectious hepatitis (hepatitis B or C, HIV infection), autoimmune hepatitis, primary biliary cirrhosis, sclerosing cholangitis, hemochromatosis, alpha1-antitrypsin deficiency, Wilson's disease, drug-induced hepatitis, alcoholic hepatitis, or are known to consume excessive amounts of alcohol
2) Patients who do not wish their medical information to be used for research purposes.
3) Patients who are judged by the physician to be unsuitable for the study.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Michihiro |
| Middle name | |
| Last name | Iwaki |
Organization
Yokohama City University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL
045-787-2800
michihir@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Michihiro |
| Middle name | |
| Last name | Iwaki |
Organization
Yokohama City University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL
045-787-2800
Homepage URL
michihir@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Saga University Hospital
Saiseikai Suita Hospital
University Hospital, Kyoto Prefectural University of Medicine
Nara City Hospital
Nagoya University Hospital
Gifu Municipal Hospital
Fukui-ken Saiseikai Hospital
Ogaki Municipal Hospital
Kawasaki Medical school General Medical Center
Osaka Metropolitan University Graduate School of Medicine
Hiroshima University Hospital
St. Marianna University Hospital
Oita Cardiovascular Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama city university, Institutional Review Board for Life Science and Medical Research Involving Human Subjects
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
Tel
045-787-2640
rinri@yokohama-cu.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）佐賀大学医学部付属病院(佐賀県)，大阪府済生会吹田病院（大阪府），京都府立医科大学附属病院（京都府），市立奈良病院（奈良県），岐阜市民病院（岐阜県），福井県済生会病院（福井県），名古屋大学医学部附属病院（愛知県），大垣市民病院（岐阜県），川崎医科大学総合医療センター（岡山県），大阪公立大学大学院医学研究科（大阪府），広島大学病院（広島県），聖マリアンナ医科大学病院（神奈川県），大分循環器病院（大分県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 28 | 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
| 2021 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Items to measure
Medical record information (existing information)
1) Background information: age, sex, height, weight, abdominal circumference, smoking history, drinking history, medical history, complications, medication history
2) Vital signs
3) Hematological tests (WBC, WBC fraction, RBC, Hb, Ht, PLT)
Biochemical tests (total protein, serum albumin, total bilirubin, direct bilirubin, AST, ALT, LDH, CRP, ALP, GGT, BUN, serum creatinine, ChE, eGFR, uric acid, Na, K, Cl, Ca, LDL-chol, HDL-chol, triglyceride, total cholesterol, fasting glucose, fasting insulin, HbA1c, ferritin, fT3, fT4, TSH)
Autoimmune disease markers (IgG, IgM, ANA, AMA, AMA-M2 antibody)
Coagulation (PT, Fibrinogen)
Others (type IV collagen 7s, Autotaxin, M2BPGi, hyaluronic acid, PNPLA3, TM6SF4, HSD17B13, AFP, AFP-L3, PIVKA-II, etc.)
4) Imaging examination (only for those who perform): ultrasound elastography, MR elastography
5) Urinalysis: General, sedimentation test
6) Pathological findings
7) Presence and nature of complications of nonalcoholic fatty liver disease
8) Prognosis (survival rate, mortality rate)
Management information
Registered date
| 2021 | Year | 12 | Month | 28 | Day |
Last modified on
| 2023 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053055
