Trial record 1 of 1 for:    Prediction of Incidence of Liver Cancer by Use of Real-time Tissue elastography
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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

May 21, 2011
May 24, 2011
September 2010
August 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01360892 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastography
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.

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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.

  • Chronic Hepatitis B
  • Chronic Hepatitis C
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
September 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
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
Japan
 
NCT01360892
JLOG1003
Yes
Japan Liver Oncology Group Organization:, Department of Gastroenterology and Hepatology, Kinki University Faculty of Medicine
Japan Liver Oncology Group
Not Provided
Study Chair: Masatoshi Kudo, Professor Kinki University Faculty of Medicine
Japan Liver Oncology Group
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP