UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045236 |
|---|---|
| Receipt number | R000051677 |
| Scientific Title | A prospective observational study in patients with chronic liver disease by magnetic resonance elastography |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2022/02/24 19:11:43 |
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Basic information
Public title
A prospective observational study in patients with chronic liver disease by magnetic resonance elastography
Acronym
A prospective observational study in patients with chronic liver disease by magnetic resonance elastography
Scientific Title
A prospective observational study in patients with chronic liver disease by magnetic resonance elastography
Scientific Title:Acronym
A prospective observational study in patients with chronic liver disease by magnetic resonance elastography
Region
| Japan |
Condition
Condition
Chronic liver disease
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Association between liver stiffness by magnetic resonance elastography and mortality and the incidence of complications (liver failure, hepatocellular carcinoma, cardiovascular disease, or other malignancies)
Basic objectives2
Others
Basic objectives -Others
Outcome investigation
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
mortality and the incidence of complications (liver failure, hepatocellular carcinoma, cardiovascular disease, or other malignancies)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with chronic liver disease who measure MRE.
Key exclusion criteria
Contraindications to MRI measurements
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Kurosaki |
Organization
Musashino Red Cross Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
180-8610
Address
1-26-1 Kyonancho Musashinoshi Tokyo 180-8610 Japan
TEL
+81-422-32-3111
kurosaki@musashino.jrc.or.jp
Public contact
Name of contact person
| 1st name | Nobuharu |
| Middle name | |
| Last name | Tamaki |
Organization
Musashino Red Cross Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
180-8610
Address
1-26-1 Kyonancho Musashinoshi Tokyo 180-8610 Japan
TEL
+81-422-32-3111
Homepage URL
nobuharu.tamaki@gmail.com
Sponsor or person
Institute
Musashino Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Musashino red cross hospital Clinical research ethics review committee
Address
1-26-1 Kyonancho Musashinoshi Tokyo 180-8610 Japan
Tel
+81-422-32-3111
kenkyu@musashino.jrc.or.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
武蔵野赤十字病院（東京都）、名寄市立総合病院（北海道）、岩手医科大学病院（岩手県）、横浜市立大学医学部付属病院（神奈川県）、東京医科大学病院（東京都）、大垣市民病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 01 | 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 | 06 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2030 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Follow-up data from the UMIN000038604 trial will also be integrated.
Management information
Registered date
| 2021 | Year | 08 | Month | 24 | Day |
Last modified on
| 2022 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051677
