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

Chronic Hepatitis B Clinical Trial

— PICTURE  

Official title:

Prediction of Incidence of Liver Cancer or PorTal Hypertension in Patients With Viral Hepatitis by Use of Real-time Tissue Elastography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01360892
• Other study ID #: JLOG1003
• Status: Recruiting
• Phase: N/A
• First received: May 21, 2011
• Last updated: May 24, 2011
• Start date: September 2010
• Est. completion date: September 2013

Study information

• Verified date: August 2010
• Source: Japan Liver Oncology Group
• Contact: Norihisa Yada, M.D.
• Phone: +81-72-366-0221
• Email: yada[@]med.kindai.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Male or female and at least 20 years of age

• Chronic hepatitis B or Chronic hepatitis C

Exclusion Criteria:

• Evidence or history of hepatocellular carcinoma

• History of alcohol abuse (alcohol intake > 20g/day)

• Pregnant or lactating patients

• Psychosis

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
Japan	Kinki University Faculty of Medicine	Osaka-sayama	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Japan Liver Oncology Group

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of carcinogenesis of hepatocellular carcinoma	Cumulative incidence of carcinogenesis of hepatocellular carcinoma defined as the time from registration to diagnosis of hepatoceluler carcinomais	every four or six months	No
Secondary	Cancer-free survival	Cancer-free survival is defined as the time from registration to death due to cencer or any cause	every four or six months	No
Secondary	Overall survival	Overall survival is defined as the time from registration to death due to any cause	one year	No
Secondary	The cumulative incidence and severity of gastro-esophageal varices	It is estimated by gastrointestinal scope for every year	one year	No
Secondary	The cumulative incidence and severity of decompensated cirrhosis	Jaundice, ascites, edema and hepatic encephalopathy etc. is evaluated as decompensated cirrhosis.	one year	No