Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastography (PICTURE)
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|ClinicalTrials.gov Identifier: NCT01360892|
Recruitment Status : Unknown
Verified August 2010 by Japan Liver Oncology Group.
Recruitment status was: Recruiting
First Posted : May 26, 2011
Last Update Posted : May 26, 2011
|Condition or disease|
|Chronic Hepatitis B Chronic Hepatitis C|
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.
Every year and for three years, we performed Real-time Tissue Elastography®, blood sampling, gastrointestinal endoscopy. If in the hospital they can perform FibroScan®, FobroScan® also be performed.
Subjects were also performed ultrasonography (US), computed sonography (CT) or magnetic resonance imaging (MRI) evry four or six months.
The time between the Real-time Tissue Elastography®, blood sampling, gastrointestinal endoscopy and FiroScan® must not exceed four weeks.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Prediction of Incidence of Liver Cancer or PorTal Hypertension in Patients With Viral Hepatitis by Use of Real-time Tissue Elastography|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||August 2013|
|Estimated Study Completion Date :||September 2013|
- Cumulative incidence of carcinogenesis of hepatocellular carcinoma [ Time Frame: every four or six months ]Cumulative incidence of carcinogenesis of hepatocellular carcinoma defined as the time from registration to diagnosis of hepatoceluler carcinomais
- Cancer-free survival [ Time Frame: every four or six months ]Cancer-free survival is defined as the time from registration to death due to cencer or any cause
- Overall survival [ Time Frame: one year ]Overall survival is defined as the time from registration to death due to any cause
- The cumulative incidence and severity of gastro-esophageal varices [ Time Frame: one year ]It is estimated by gastrointestinal scope for every year
- The cumulative incidence and severity of decompensated cirrhosis [ Time Frame: one year ]Jaundice, ascites, edema and hepatic encephalopathy etc. is evaluated as decompensated cirrhosis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01360892
|Contact: Norihisa Yada, M.D.||+81-72-366-0221 ext email@example.com|
|Contact: Kazuomi Ueshima, M.D.||+81-72-366-0221 ext firstname.lastname@example.org|
|Kinki University Faculty of Medicine||Recruiting|
|Osaka-sayama, Osaka, Japan, 589-8511|
|Contact: Norihisa Yada, M.D. +81-72-366-0221 ext 3525 email@example.com|
|Contact: Kazuomi Ueshima, M.D. +81-72-366-0221 ext 3525 firstname.lastname@example.org|
|Study Chair:||Masatoshi Kudo, Professor||Kinki University Faculty of Medicine|