Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastography (PICTURE)
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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 |
- 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
- 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) |
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 |
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.
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| 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 | |
| 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 | |
| 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:
|
Liver Neoplasms Liver Diseases Digestive System Neoplasms Neoplasms by Site Neoplasms Hepatitis Hepatitis A Hepatitis B Hepatitis, Chronic Hepatitis C Hypertension, Portal |
Hepatitis B, Chronic Hepatitis C, Chronic Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on May 23, 2013