UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043904 |
|---|---|
| Receipt number | R000049364 |
| Scientific Title | clinical usefulness of M2BPGi for detecting patients with liver disease progression |
| Date of disclosure of the study information | 2021/04/15 |
| Last modified on | 2021/04/13 05:57:50 |
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Basic information
Public title
clinical usefulness of M2BPGi for detecting patients with liver disease progression
Acronym
clinical usefulness of M2BPGi for detecting patients with liver disease progression
Scientific Title
clinical usefulness of M2BPGi for detecting patients with liver disease progression
Scientific Title:Acronym
clinical usefulness of M2BPGi for detecting patients with liver disease progression
Region
| Japan |
Condition
Condition
Liver dysfunction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Fatty liver accounts for the majority of liver dysfunction in adult health examinations, and it is estimated that about 30% of adults are affected. However, fatty liver itself is not regarded as a disease and tends to be neglected, and even if it is pointed out in a medical examination, it does not lead to a medical examination because there are almost no subjective symptoms. There are some cases that end up. Therefore, if liver dysfunction or fatty liver is pointed out in the medical examination, some motivation is required to lead to a secondary detailed examination. In this study, we focus on the fact that M2BPGi suggests the progression of liver disease, and clarify its usefulness in picking up liver disease and motivating consultation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Clarify the clinical significance of M2BPGi in efficient liver disease pick-up and motivation for consultation.
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
Nagawa Town Citizens' Dock and Specific Medical Examination (biennial) examinees and members of the Japan Health Insurance Association, etc.
Key exclusion criteria
Residents who did not consent to this research test. Patients who have already been diagnosed with viral hepatitis and have started treatment. Patients who cannot receive medical examinations because they require nursing care 3 or more
Target sample size
3900
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Joshita |
Organization
Shinshu University School of Medicine
Division name
Department of Medicine, Division of Gastroenterology and Hepatology
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano , Japan
TEL
0263-37-2634
ninai@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Joshita |
Organization
Shinshu University School of Medicine
Division name
Department of Medicine, Division of Gastroenterology and Hepatology
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano , Japan
TEL
0263-37-2634
Homepage URL
ninai@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Sysmex Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yodakubo Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University School of Medicine
Address
3-1-1 Asahi, Matsumoto, Nagano , Japan
Tel
0263-37-2634
ninai@shinshu-u.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 12 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2021 | Year | 04 | Month | 13 | Day |
Last modified on
| 2021 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049364
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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