Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastography (PICTURE)
|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.
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|