UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031374 |
|---|---|
| Receipt number | R000035783 |
| Scientific Title | Study for the correlation between liver fibrosis, steatosis and prognosis of the patients by using abdominal ultrasonography |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2019/01/17 20:25:34 |
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Basic information
Public title
Study for the correlation between liver fibrosis, steatosis and prognosis of the patients by using abdominal ultrasonography
Acronym
Study for the correlation between liver fibrosis, steatosis and prognosis of the patients by using abdominal ultrasonography
Scientific Title
Study for the correlation between liver fibrosis, steatosis and prognosis of the patients by using abdominal ultrasonography
Scientific Title:Acronym
Study for the correlation between liver fibrosis, steatosis and prognosis of the patients by using abdominal ultrasonography
Region
| Japan |
Condition
Condition
liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the utility of measuring liver and spleen stiffness and steatosis using ultrasonography as an alternation of liver biopsy, by evaluating the relationship between clinical data and clinical course and investigate the prognosis of patients with liver disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
appearance of liver failure(ascites, edema and rupture of esophageal-gastric varies)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
all patients those who we operate abdominal ultrasonography
Key exclusion criteria
those who cannot obtain consent to participate in this study
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masatoshi Ishigami |
Organization
Nagoya university hospital
Division name
department of gastroenterology and hepatology
Zip code
Address
Tsuruma-cho 65, Showa-ku, Nagoya, Aichi
TEL
052-741-2111
masaishi@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Youji Ishizu |
Organization
Nagoya university hospital
Division name
department of gastroenterology and hepatology
Zip code
Address
Tsuruma-cho 65, Showa-ku, Nagoya, Aichi
TEL
052-741-2111
Homepage URL
y-ishizu@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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 | 03 | 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
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
| 2018 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | 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
Management information
Registered date
| 2018 | Year | 02 | Month | 19 | Day |
Last modified on
| 2019 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035783
