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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017020
Receipt No. 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

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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
Last 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)
Email tkumada@he.mirai.ne.jp

Public contact
1st 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
Email tkumada@he.mirai.ne.jp

Sponsor
Institute Department of Gastroenterology, Ogaki Municipal Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019740

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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