Hepatitis B VirusNCT00912847
Validity and Cost-Effectiveness of a New Screening Test for Hepatocellular Carcinoma
An observational study of Hepatitis B Virus, run by Chinese University of Hong Kong.
Trial summary
The purpose of this study is: 1. To establish and compare the diagnostic utilities for hepatocellular carcinoma (HCC) screening tests of (a) HS-AFP, (b) AFP + US,(c) AFP alone and (d) US alone (within HBV carriers between age 40 and 70 years); 2. To establish the cost-effectiveness of the screening tests; 3. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Hepatitis B Virus
- How many people
- 1,018 participants
- Where
- No sites listed yet
- Study dates
- Oct 1997to Apr 2004
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HBV carriers between age 40 and 70 years
Who may be able to join
- Age between 40 and 70 years
- Seropositive for HBsAg
- Child's A or B
- Life expectancy of more than 2 years
Who cannot join
- Non-HBV related cirrhosis
- History of malignancy
About this study
The purpose of this study is:
- To establish and compare the diagnostic utilities for hepatocellular carcinoma (HCC) screening tests of (a) HS-AFP, (b) AFP + US,(c) AFP alone and (d) US alone (within HBV carriers between age 40 and 70 years);
- To establish the cost-effectiveness of the screening tests;
- To compare tumor sizes, resection rates, and survival rates up to 18 months between those who were screened by HS-AFP those of a historical control group that was not screened.
- Conditions
- Hepatitis B Virus
- Keywords
- HBV carriers
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| JHC | AFP > 20 ng/ml and USG positive | |
| Non JHC | patient without AFP > 20 or USG negative |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startOct 1997
- Primary completionApr 2004
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B VirusStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- 1,018 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912847
- Sponsor's protocol ID
- RHCC002
- Status last verified
- Jun 2009
- First submitted
- 1 Jun 2009
- Last updated
- 3 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Cost-Effectiveness of a New Screening Test for Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00912847
- Acronym / sponsor ID
- RHCC002
- Conditions
- Hepatitis B Virus
- Keywords
- HBV carriers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,018 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Oct 1997
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 3 Jun 2009 (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.
The purpose of this study is:
- To establish and compare the diagnostic utilities for hepatocellular carcinoma (HCC) screening tests of (a) HS-AFP, (b) AFP + US,(c) AFP alone and (d) US alone (within HBV carriers between age 40 and 70 years);
- To establish the cost-effectiveness of the screening tests;
- To compare tumor sizes, resection rates, and survival rates up to 18 months between those who were screened by HS-AFP those of a historical control group that was not screened.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JHC | – | –AFP > 20 ng/ml and USG positive |
| Non JHC | – | –patient without AFP > 20 or USG negative |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HBV carriers between age 40 and 70 years
Key inclusion criteria (4 listed)
- Age between 40 and 70 years
- Seropositive for HBsAg
- Child's A or B
- Life expectancy of more than 2 years
Key exclusion criteria (2 listed)
- Non-HBV related cirrhosis
- History of malignancy
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B Virus, run by Chinese University of Hong Kong.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 3 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 3 Jun 2009.