PICTURE: Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastography

Sponsor

Japan Liver Oncology Group (Other)

Overall Status

Unknown status

CT.gov ID

NCT01360892

Collaborator

(none)

1,000

Enrollment

Location

Duration (Months)

27.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multi-center cohort study in which the Real-time Tissue Elastography® measurements will predict prospectively the incidence of hepatocellular carcinoma, the incidence and severity of gastroesophageal varices ascites and decompensated cirrhosis in hepatitis B or C patients.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis B Chronic Hepatitis C

Detailed Description

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 Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Time Perspective:

Prospective

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 :

Sep 1, 2010

Anticipated Primary Completion Date :

Aug 1, 2013

Anticipated Study Completion Date :

Sep 1, 2013

Outcome Measures

Primary Outcome Measures

Cumulative incidence of carcinogenesis of hepatocellular carcinoma [every four or six months]
Cumulative incidence of carcinogenesis of hepatocellular carcinoma defined as the time from registration to diagnosis of hepatoceluler carcinomais

Secondary Outcome Measures

Cancer-free survival [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 [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 [one year]
It is estimated by gastrointestinal scope for every year
The cumulative incidence and severity of decompensated cirrhosis [one year]
Jaundice, ascites, edema and hepatic encephalopathy etc. is evaluated as decompensated cirrhosis.