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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004432
Receipt No. R000005288
Scientific Title Prediction of Incidence of Liver Cancer or PorTal Hypertension in Patients With Viral Hepatitis by Use of Real-time Tissue Elastography
Date of disclosure of the study information 2010/10/21
Last modified on 2013/09/04

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Basic information
Public title Prediction of Incidence of Liver Cancer or PorTal Hypertension in Patients With Viral Hepatitis by Use of Real-time Tissue Elastography
Acronym PICTURE Study
Scientific Title Prediction of Incidence of Liver Cancer or PorTal Hypertension in Patients With Viral Hepatitis by Use of Real-time Tissue Elastography
Scientific Title:Acronym PICTURE Study
Region
Japan

Condition
Condition Chronic Hepatitis B
Chronic Hepatitis C
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to validate the predictive value of Real-time Tissue Elastography by comparison with serum marker or FibroScan in chronic hepatitis B or C patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cumulative incidence of carcinogenesis of hepatocellular carcinoma
Key secondary outcomes * Cancer-free survival
* Overall survival
* The cumulative incidence and severity of gastro-esophageal varices
* The cumulative incidence and severity of decompensated cirrhosis

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

Not applicable
Gender Male and Female
Key inclusion criteria * Male or female and at least 20 years of age
* Chronic hepatitis B or Chronic hepatitis C
Key exclusion criteria * Evidence or history of hepatocellular carcinoma
* History of alcohol abuse (alcohol intake > 20g/day)
* Pregnant or lactating patients
* Psychosis
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatoshi Kudo
Organization Kinki University Faculty of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan
TEL 072-366-0221
Email m-kudo@med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Norihisa Yada
Organization Kinki University Faculty of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan
TEL 072-366-0221
Homepage URL
Email yada@med.indai.ac.jp

Sponsor
Institute Research Program of medical disease field of incurable diseases and cancer
&laquo;Field of hepatitis related research areas&raquo; provided dy the Ministry of Health Labor, and Welfare of Japan.
Institute
Department

Funding Source
Organization Research Program of medical disease field of incurable diseases and cancer
&laquo;Field of hepatitis related research areas&raquo; provided dy the Ministry of Health Labor, and Welfare of Japan.
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
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

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 21 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
2010 Year 08 Month 12 Day
Date of IRB
Anticipated trial start date
2010 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 test

Management information
Registered date
2010 Year 10 Month 21 Day
Last modified on
2013 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005288

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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