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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Japan Liver Oncology Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Japan Liver Oncology Group
ClinicalTrials.gov Identifier:
NCT01360892
First received: May 21, 2011
Last updated: May 24, 2011
Last verified: August 2010
  Purpose

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
Chronic Hepatitis B
Chronic Hepatitis C

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Japan Liver Oncology Group:

Primary Outcome Measures:
  • Cumulative incidence of carcinogenesis of hepatocellular carcinoma [ Time Frame: every four or six months ] [ Designated as safety issue: No ]
    Cumulative incidence of carcinogenesis of hepatocellular carcinoma defined as the time from registration to diagnosis of hepatoceluler carcinomais


Secondary Outcome Measures:
  • Cancer-free survival [ Time Frame: every four or six months ] [ Designated as safety issue: No ]
    Cancer-free survival is defined as the time from registration to death due to cencer or any cause

  • Overall survival [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    It is estimated by gastrointestinal scope for every year

  • The cumulative incidence and severity of decompensated cirrhosis [ Time Frame: one year ] [ Designated as safety issue: No ]
    Jaundice, ascites, edema and hepatic encephalopathy etc. is evaluated as decompensated cirrhosis.


Estimated Enrollment: 1000
Study Start Date: September 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360892

Contacts
Contact: Norihisa Yada, M.D. +81-72-366-0221 ext 3525 yada@med.kindai.ac.jp
Contact: Kazuomi Ueshima, M.D. +81-72-366-0221 ext 3525 kaz-ues@med.kindi.ac.jp

Locations
Japan
Kinki University Faculty of Medicine Recruiting
Osaka-sayama, Osaka, Japan, 589-8511
Contact: Norihisa Yada, M.D.    +81-72-366-0221 ext 3525    yada@med.kindai.ac.jp   
Contact: Kazuomi Ueshima, M.D.    +81-72-366-0221 ext 3525    kaz-ues@med.kindi.ac.jp   
Sponsors and Collaborators
Japan Liver Oncology Group
Investigators
Study Chair: Masatoshi Kudo, Professor Kinki University Faculty of Medicine
  More Information

No publications provided

Responsible Party: Japan Liver Oncology Group Organization:, Department of Gastroenterology and Hepatology, Kinki University Faculty of Medicine
ClinicalTrials.gov Identifier: NCT01360892     History of Changes
Other Study ID Numbers: JLOG1003
Study First Received: May 21, 2011
Last Updated: May 24, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Liver Oncology Group:
Hepatitis B virus
Hepatitis C virus
Chronic hepatitis
Liver chlorosis
Liver stiffness
Liver fibrosis

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Neoplasms
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Flaviviridae Infections
Digestive System Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on September 16, 2014