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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041196
Receipt No. R000047037
Scientific Title Multicentral study for evaluating hepatic steatosis using Ultrasound-guided attenuation parameter (UGAP) by comparison with MRI-determined proton density fat fraction (PDFF)
Date of disclosure of the study information 2020/08/01
Last modified on 2020/07/22

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Basic information
Public title Multicentral study for evaluating hepatic steatosis using Ultrasound-guided attenuation parameter (UGAP) by comparison with MRI-determined proton density fat fraction (PDFF)
Acronym Ultrasound-guided attenuation parameter (UGAP) study
Scientific Title Multicentral study for evaluating hepatic steatosis using Ultrasound-guided attenuation parameter (UGAP) by comparison with MRI-determined proton density fat fraction (PDFF)
Scientific Title:Acronym Ultrasound-guided attenuation parameter (UGAP) study
Region
Japan

Condition
Condition Chronic liver disease
Classification by specialty
Hepato-biliary-pancreatic medicine Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of hepatic steatosis by UGAP
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes We assess the accuracy of UGAP in assessing hepatic steatosis compared to PDFF
Key secondary outcomes We verify whether UGAP can diagnose fatty liver (liver fat content 5% or more)

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
90 years-old >=
Gender Male and Female
Key inclusion criteria 1.Patients who underwent UGAP and PDFF within 3 months
2.Patients with chronic liver disease including viral hepatitis, NAFLD, autoimmune hepatitis, primary biliary cholangitis, and so on
3.Patients who can follow instructions such as breath-holding.
Key exclusion criteria 1.Patients without claustrophobia
2.Patients without magnetic substance or tattoo
3.Patients without pacemakers
4.Patients judged as inappropriate for the study by the study responsibility (share) physician.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Hidenori
Middle name
Last name Toyoda
Organization Ogaki Municipal Hospital
Division name Department of Gastroenterology and Hepatology
Zip code 5038502
Address 4-86 Minaminokawa-cho, Ogaki-shi, Gifu-ken
TEL +81-584-81-3341
Email hmtoyoda@spice.ocn.ne.jp

Public contact
Name of contact person
1st name Kumada
Middle name
Last name Takashi
Organization Gifu Kyoritsu University
Division name Department of Nursing, Faculty of Nursing,
Zip code 5038550
Address 5-50, Kitagata-cho, Ogaki-shi, Gifu-ken
TEL +81-584-77-3512
Homepage URL
Email takashi.kumada@gmail.com

Sponsor
Institute Ogaki Municipal Hospital
Institute
Department

Funding Source
Organization GE Precision Healthcare
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization USA

Other related organizations
Co-sponsor Nayoro City General Hospital
Iwate Medical University
Yokohama City University
Musashino Red-Cross Hospital
Tokyo Medical University
Gifu Kyoritsu University
Name of secondary funder(s) None

IRB Contact (For public release)
Organization Ogaki Municipal Hospital
Address 4-86 Minaminokawa, Ogaki, Gifu, Japan, 503-8502
Tel +81-584-81-3341
Email clinical-trial@omh.ogaki.gifu.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
2020 Year 08 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 1000
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
2019 Year 07 Month 22 Day
Date of IRB
2019 Year 08 Month 23 Day
Anticipated trial start date
2020 Year 02 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2021 Year 09 Month 30 Day

Other
Other related information Evidence of the superiority of UGAP methods for the detection and quantification of the hepatic steatosis. Acquisition of the optimal cut-off values for the diagnosis of hepatic steatosis. Academical manuscripts and clinical presentations on the results.

Management information
Registered date
2020 Year 07 Month 22 Day
Last modified on
2020 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047037

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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