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

NCT01360892 | Unknown DMC

• 1 other identifier: JLOG1003
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Hepatitis B; Chronic Hepatitis C

Keywords

Hepatitis B virus; Hepatitis C virus; Chronic hepatitis; Liver chlorosis; Liver stiffness; Liver fibrosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Cancer-free survival

  every four or six months

• Overall survival

  one year

• The cumulative incidence and severity of gastro-esophageal varices

  one year

• The cumulative incidence and severity of decompensated cirrhosis

  one year

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Male or female and at least 20 years of age
• Chronic hepatitis B or Chronic hepatitis C

You may not qualify if:

• Evidence or history of hepatocellular carcinoma
• History of alcohol abuse (alcohol intake \> 20g/day)
• Pregnant or lactating patients
• Psychosis

Sponsors & Collaborators

• Kindai University: lead

Study Sites (1)

Kinki University Faculty of Medicine

Ōsaka-sayama, Osaka, 589-8511, Japan

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis C, Chronic; Hepatitis B; Hepatitis C; Hepatitis, Chronic; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Flaviviridae Infections; RNA Virus Infections; Fibrosis

Study Officials

• Masatoshi Kudo, Professor

  Kinki University Faculty of Medicine

  STUDY CHAIR

Central Study Contacts

Norihisa Yada, M.D.

CONTACT

+81-72-366-0221; yada@med.kindai.ac.jp

Kazuomi Ueshima, M.D.

CONTACT

+81-72-366-0221; kaz-ues@med.kindi.ac.jp

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 21, 2011
• First Posted: May 26, 2011
• Study Start: September 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2013
• Last Updated: May 26, 2011

Record last verified: 2010-08

Locations

JP (1)