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

May 24, 2011 updated by: Kindai University

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Japan
    • Osaka
      • Osaka-sayama, Osaka, Japan, 589-8511
        • Recruiting
        • Kinki University Faculty of Medicine
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects with chronic hepatitis B or C will be eligible for the study. Subjects with other infectious viral diseases or chronic liver disease are excluded for study enrollment.

Real-time Tissue Elastography®, serum maker and gastrointestinal endoscopy are performed. If in the hopsital they can perform FibroScan®, FobroScan® also be performed.

The time between the Real-time Tissue Elastography®, blood sampling, FiroScan® must not exceed four weeks.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
every four or six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
every four or six months
Overall survival
Time Frame: one year
Overall survival is defined as the time from registration to death due to any cause
one year
The cumulative incidence and severity of gastro-esophageal varices
Time Frame: one year
It is estimated by gastrointestinal scope for every year
one 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.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kindai University

Investigators

  • Study Chair: Masatoshi Kudo, Professor, Kinki University Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

August 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

May 21, 2011

First Submitted That Met QC Criteria

May 24, 2011

First Posted (Estimate)

May 26, 2011

Study Record Updates

Last Update Posted (Estimate)

May 26, 2011

Last Update Submitted That Met QC Criteria

May 24, 2011

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JLOG1003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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