UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021809 |
|---|---|
| Receipt number | R000024075 |
| Scientific Title | Cohort study of liver pathogenesis by MR elastography and/or transient elastography in nonalcoholic fatty liver disease |
| Date of disclosure of the study information | 2016/04/07 |
| Last modified on | 2021/04/05 21:45:05 |
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Basic information
Public title
Cohort study of liver pathogenesis by MR elastography and/or transient elastography in nonalcoholic fatty liver disease
Acronym
Cohort study of liver pathogenesis by MR elastography and/or transient elastography in nonalcoholic fatty liver disease
Scientific Title
Cohort study of liver pathogenesis by MR elastography and/or transient elastography in nonalcoholic fatty liver disease
Scientific Title:Acronym
Cohort study of liver pathogenesis by MR elastography and/or transient elastography in nonalcoholic fatty liver disease
Region
| Japan |
Condition
Condition
nonalcoholic fatty liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the time-dependent change of liver pathogenesis by using MR elastography and transient elastgraphy in patients with nonalcoholic fatty liver disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess the time-dependent change of liver fibrosis and liver steatosis by using MR elastography and transient elastgraphy in patients with nonalcoholic fatty liver disease.
Key secondary outcomes
To assess the time-dependent change of liver inflammation and liver iron metabolism by using MR elastography and transient elastgraphy in patients with nonalcoholic fatty liver disease.
To assess the time-dependent change of hematological examination in patients with nonalcoholic fatty liver disease.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients with suspected NAFLD by interview, blood collection, imaging studies.
2. Patients who are provided a written informed consent, and do not meet the below exclusion criteria.
Key exclusion criteria
1. MRI examination is impossible (ex. Installation of pacemaker, claustrophobia)
2. Pregnant patients
3. In the opinion of the investigator, patient is unsuitable as a study subject.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Ogawa |
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
045-787-2640
ogaway@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Ogawa |
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
045-787-2640
Homepage URL
ogaway@yokohama-cu.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
Local Government
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 Fukuura,Kanazawaku, Yokohama
Tel
045-787-2800
ogaway@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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 07 | 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
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 02 | Month | 28 | Day |
Other
Other related information
To assess the time-dependent change of liver pathogenesis by using MR elastography and transient elastgraphy.
Management information
Registered date
| 2016 | Year | 04 | Month | 07 | 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=R000024075
