Chronic Hepatitis BPICTURENCT01360892
Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastography
An observational study of Chronic Hepatitis B and Chronic Hepatitis C, run by Kindai University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Hepatitis B, Chronic Hepatitis C
- How many people
- 1,000 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2010to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Male or female and at least 20 years of age
- Chronic hepatitis B or Chronic hepatitis C
Who cannot join
- Evidence or history of hepatocellular carcinoma
- History of alcohol abuse (alcohol intake > 20g/day)
- Pregnant or lactating patients
- Psychosis
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Kinki University Faculty of Medicine
Ōsaka-sayama, Osaka, 589-8511
Norihisa Yada, M.D., +81-72-366-0221 ext. 3525, yada@med.kindai.ac.jp
Kazuomi Ueshima, M.D., +81-72-366-0221 ext. 3525, kaz-ues@med.kindi.ac.jp
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Hepatitis B, Chronic Hepatitis C
- Keywords
- Hepatitis B virus, Hepatitis C virus, Chronic hepatitis, Liver chlorosis, Liver stiffness, Liver fibrosis
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis C, Chronic, Hepatitis B, Hepatitis C, Hepatitis, Chronic, Liver Cirrhosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: every four or six months
Secondary outcomes (4)
Cancer-free survival
Cancer-free survival is defined as the time from registration to death due to cencer or any cause
Measured: every four or six months
Overall survival
Overall survival is defined as the time from registration to death due to any cause
Measured: one year
The cumulative incidence and severity of gastro-esophageal varices
It is estimated by gastrointestinal scope for every year
Measured: one year
The cumulative incidence and severity of decompensated cirrhosis
Jaundice, ascites, edema and hepatic encephalopathy etc. is evaluated as decompensated cirrhosis.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2011 (estimated)
- Study startSep 2010
- Primary completionAug 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kindai University
- Sponsor type
- University, hospital or other
- Investigators
- Masatoshi Kudo, Professor, Study chair, Kinki University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360892
- Sponsor's protocol ID
- JLOG1003
- Acronym
- PICTURE
- Status last verified
- Aug 2010
- First submitted
- 21 May 2011
- Last updated
- 26 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Incidence of Liver Cancer or PorTal Hypertension in Patients With Viral Hepatitis by Use of Real-time Tissue Elastography
- ClinicalTrials.gov ID
- NCT01360892
- Acronym / sponsor ID
- PICTURE / JLOG1003
- Conditions
- Chronic Hepatitis B, Chronic Hepatitis C
- Keywords
- Hepatitis B virus, Hepatitis C virus, Chronic hepatitis, Liver chlorosis, Liver stiffness, Liver fibrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Kindai UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 26 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Male or female and at least 20 years of age
- Chronic hepatitis B or Chronic hepatitis C
Key exclusion criteria (4 listed)
- Evidence or history of hepatocellular carcinoma
- History of alcohol abuse (alcohol intake > 20g/day)
- Pregnant or lactating patients
- Psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Cancer-free survival
Time frame: every four or six months
Overall survival
Time frame: one year
The cumulative incidence and severity of gastro-esophageal varices
Time frame: one year
The cumulative incidence and severity of decompensated cirrhosis
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masatoshi Kudo, Professor study chair
Kinki University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis B and Chronic Hepatitis C, run by Kindai University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Norihisa Yada, M.D. (+81-72-366-0221 ext. 3525, yada@med.kindai.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of carcinogenesis of hepatocellular carcinoma (time frame: every four or six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2011.