UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053147 |
|---|---|
| Receipt number | R000060641 |
| Scientific Title | The diagnostic ability for hepatic steatosis using Liver Fat Quantification in EPIC(Philips) |
| Date of disclosure of the study information | 2023/12/20 |
| Last modified on | 2023/12/17 20:51:40 |
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Basic information
Public title
The diagnostic ability for hepatic steatosis using Liver Fat Quantification in EPIC(Philips)
Acronym
The diagnostic ability for hepatic steatosis using Liver Fat Quantification in EPIC(Philips)
Scientific Title
The diagnostic ability for hepatic steatosis using Liver Fat Quantification in EPIC(Philips)
Scientific Title:Acronym
The diagnostic ability for hepatic steatosis using Liver Fat Quantification
Region
| Japan |
Condition
Condition
chronic hepatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examin the diagnostic ability for hepatic steatosis using Liver Fat Quantification(LFQ)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The diagnostic ability for hepatic steatosis of LFQ using MRI-PDFF or hepatic histological evaluation as refarence stabdard
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
1. Chronic hepatitis patients who can sign a informed consent form and express their intention to participate in the study
2. Chronic hepatitis patients who have performed MRI-PDFF or liver biopsy within 3 months of measuring LFQ
3.Chrnonic hepatitis patients performed abdominal ultrasound examination
Key exclusion criteria
1. Chronic hepatitis patients who have difficulty understanding ultrasound examinations and research content
2. Chronic hepatitis patients who cannot lie with supine position in measuring LFQ.
3. Chronic hepatitis patients under 18 years old
4. Chronic hepatitis patinets with ascites.
5. Chronic hepatitis patients who are judged unsuitable by physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Nishimura |
Organization
Hyogo Medical University
Division name
Department of Gastroenterology/Ultrasound Imaging Center
Zip code
663-8501
Address
1-1, Mukogawa-cho, Nishinomiya-city, Hyogo prefecture
TEL
0798-45-6472
tk-nishimura@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Nishimura |
Organization
Hyogo Medical University
Division name
Department of Gastroenterology/Ultrasound Imaging Center
Zip code
663-8501
Address
1-1, Mukogawa-cho, Nishinomiya-city, Hyogo prefecture
TEL
0798-45-6472
Homepage URL
tk-nishimura@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Funding Source
Organization
Philips Japan
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Division of Hepatology, Department of Internal Medicine, Iwate Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Medical University
Address
1-1, Mukogawa-cho, Nishinomiya-city Hyogo prefecture
Tel
0798456111
rinri@hyo-med.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
兵庫医科大学 消化器内科学/超音波センター（兵庫県）
岩手医科大学 内科学講座消化器内科学分野（岩手県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 20 | 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
261
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective study
Management information
Registered date
| 2023 | Year | 12 | Month | 18 | Day |
Last modified on
| 2023 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060641
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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