UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017020 |
|---|---|
| Receipt number | R000019740 |
| Scientific Title | Changes in non-hypervascular hypointense nodules during hepatobiliary phase of Gd-EOB-DTPA enhanced MRI in patients with chronic hepatitis C after the eradication of HCV |
| Date of disclosure of the study information | 2015/04/15 |
| Last modified on | 2017/07/13 08:05:56 |
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Basic information
Public title
Changes in non-hypervascular hypointense nodules during hepatobiliary phase of Gd-EOB-DTPA enhanced MRI in patients with chronic hepatitis C after the eradication of HCV
Acronym
Changes in non-hypervascular hypointense nodules during hepatobiliary phase of Gd-EOB-DTPA enhanced MRI in patients with chronic hepatitis C after the eradication of HCV
Scientific Title
Changes in non-hypervascular hypointense nodules during hepatobiliary phase of Gd-EOB-DTPA enhanced MRI in patients with chronic hepatitis C after the eradication of HCV
Scientific Title:Acronym
Changes in non-hypervascular hypointense nodules during hepatobiliary phase of Gd-EOB-DTPA enhanced MRI in patients with chronic hepatitis C after the eradication of HCV
Region
| Japan |
Condition
Condition
Patients with chronic HCV infection who are planning to undergo antiviral therapy for HCV
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Serial observation of non-hypervascular hypointense nodules during hepatobiliary phase of Gd-EOB-DTPA enhanced MRI including the evolution to hepatocellular carcinoma after the eradication of HCV in patients with chronic hepatitis C.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serial changes of non-hypervascular hypointense nodules during hepatobiliary phase of Gd-EOB-DTPA enhanced MRI after the eradication of HCV in patients with chronic hepatitis C.
Key secondary outcomes
The incidence of the evolution of non-hypervascular hypointense nodules during hepatobiliary phase of Gd-EOB-DTPA enhanced MRI to hyper vascular tumors including hepatocellular carcinoma.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with chronic HCV infection who are planning to undergo antiviral therapy for HCV.
Key exclusion criteria
Patients who have a history of hepatocellular carcinoma.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidenori Toyoda |
Organization
Ogaki Municipal Hospital
Division name
Gastroenterology
Zip code
Address
4-86, Minaminokawa, Ogaki, Gifu
TEL
0584-81-3341(1563)
tkumada@he.mirai.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidenori Toyoda |
Organization
Ogaki Municipal Hospital
Division name
Gastroenterology
Zip code
Address
4-86, Minaminokawa, Ogaki, Gifu
TEL
0584-81-3341(1563)
Homepage URL
tkumada@he.mirai.ne.jp
Sponsor or person
Institute
Department of Gastroenterology, Ogaki Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
大垣市民病院（岐阜県）
（Ogaki Municipal Hospital）
Other administrative information
Date of disclosure of the study information
| 2015 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 07 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation will be continued for maximum 10 years for patients with non-hypervascular hypo intense nodules by Gd-EOB-DTPA enhanced MRI who achieved the eradication of HCV.
Management information
Registered date
| 2015 | Year | 04 | Month | 02 | Day |
Last modified on
| 2017 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019740
