UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034136 |
|---|---|
| Receipt number | R000038915 |
| Scientific Title | MRI-based assessment of the risk factor for hepatocellular carcinoma of chronic hepatitis type C after anti-viral therapy |
| Date of disclosure of the study information | 2018/09/14 |
| Last modified on | 2018/09/14 10:24:43 |
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Basic information
Public title
MRI-based assessment of the risk factor for hepatocellular carcinoma of chronic hepatitis type C after anti-viral therapy
Acronym
MRI for stratifying the risk of HCC after SVR by DAA
Scientific Title
MRI-based assessment of the risk factor for hepatocellular carcinoma of chronic hepatitis type C after anti-viral therapy
Scientific Title:Acronym
MRI for stratifying the risk of HCC after SVR by DAA
Region
| Japan |
Condition
Condition
Type C hepatitis
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To stratify the risk of HCC development in patients who had had type C hepatitis and have obtained SVR by DAA treatment
Basic objectives2
Others
Basic objectives -Others
MRI is being used for the screening of HCC in patients with chronic liver disease. Gadoxetic acid-enhanced hepatobiliary phase (HBP) hypointense nodule without arterial phase hyper enhancement is considered to become hyper vascular HCC over time. In this study, we aimed to stratify the risk of HCC development in patients who had had type C hepatitis and have achieved SVR by DAA treatment using the MRI findings obtained after achieving SVR.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HCC development
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 who have achieved SVR within 1 year or who is scheduled to receive DAA treatment
Key exclusion criteria
Patients who have not achieved SVR by DAA
Patients who cannot undergo MRI within 1 year after SVR.
Patients of <18 years old
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Utaroh Motosugi |
Organization
University of Yamanashi
Division name
Radiology
Zip code
Address
1110 Shimokato, Chuo-Shi, Yamanashi
TEL
055-273-1111
umotosugi@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Utaroh Motosugi |
Organization
University of Yamanashi
Division name
Radiology
Zip code
Address
1110 Shimokato, Chuo-Shi, Yamanashi
TEL
055-273-1111
Homepage URL
umotosugi@yamanashi.ac.jp
Sponsor or person
Institute
Department of Radiology, University of Yamanashi
Institute
Department
Personal name
Funding Source
Organization
Bayer Healthcare
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 09 | Month | 14 | 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
| 2017 | Year | 03 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2018 | Year | 09 | Month | 14 | Day |
Last modified on
| 2018 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038915
