UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007496 |
|---|---|
| Receipt number | R000008850 |
| Scientific Title | The analysis of hypo vascular nodules detected by EOB-MRI |
| Date of disclosure of the study information | 2012/03/14 |
| Last modified on | 2013/06/11 17:19:45 |
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Basic information
Public title
The analysis of hypo vascular nodules detected by EOB-MRI
Acronym
CHARM STUDY
Scientific Title
The analysis of hypo vascular nodules detected by EOB-MRI
Scientific Title:Acronym
CHARM STUDY
Region
| Japan |
Condition
Condition
Liver cirrhosis (High risk groups of HCC)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The incidence of HCC among the patients with hypo vascular nodules detected by hepatocyte phase of EOB-MRI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of incidence of HCC
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
PLT<120000
without HCC
good general condition
Key exclusion criteria
eGFR>30mL/min
T-bil>3.0
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuteru Kondo |
Organization
Tohoku University Hospital
Division name
Division of Gastroenterology
Zip code
Address
1-1 Seiryo, Aoba, Sendai City, Miyagi
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuteru Kondo |
Organization
Tohoku University Hospital
Division name
Division of Gastroenterology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Division of Gastroenterology, Tohoku University Hospital
Organization
Division
Category of Funding 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
| 2012 | Year | 03 | 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
| 2012 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recruiting
Management information
Registered date
| 2012 | Year | 03 | Month | 13 | Day |
Last modified on
| 2013 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008850
