Chronic Hepatitis BNCT02817685
Follow-up Strategy of Chronic Hepatitis B for Early Detection and Diagnosis of Hepatocellular Carcinoma: A Randomized Control Trial
An observational study of Chronic Hepatitis B, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
This study is a randomized control prospective study. The aim of this study is to establish an all-round and convenient follow-up strategy of Chronic Hepatitis B for early detection and diagnosis of Hepatocellular Carcinoma (HCC), by investigating whether different surveillance time intervals and surveillance methods… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- 3 months, 6 months and 3 month ultrasound(US)+3 month CT/MRI+3 month US+3 month CT/MRI
- How many people
- 7,660 participants
- Where
- 1 siteChina
- Study dates
- May 2016to May 2020
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic Hepatitis B patients
Who may be able to join
- HBV-Ag positive( >6 months)
- age among 18 and 80 years
Who cannot join
- patients with hepatocellular carcinoma
- patients were diagnosis hepatocellular carcinoma within 3 months of inclusion;
- patients with alcoholic hepatitis or autoimmune hepatitis
- patients with severe uncontrolled disease resulting in estimated life expectance less than 1 year
- coinfection with human immunodeficiency virus(HIV)
- cannot undergo contrast-enhanced imaging
- refuse attending the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The department of Ultrasound, the third affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong
Zhongzhen zz Su, doctor, 0086-020-85252010, sp9313@126.com
About this study
This study is a randomized control prospective study. The aim of this study is to establish an all-round and convenient follow-up strategy of Chronic Hepatitis B for early detection and diagnosis of Hepatocellular Carcinoma (HCC), by investigating whether different surveillance time intervals and surveillance methods are beneficial for chronic hepatitis B and cirrhotic patients with different risk of HCC.
Read the detailed description
Surveillance of chronic hepatitis B and cirrhotic patients had been demonstrated to increase chances of curative treatment for hepatocellular carcinoma. However, the optimal surveillance interval for different risk patients is still controversial. The AASLD and EASL-EORTC guidelines recommend chronic hepatitis B patients undergoing ultrasound surveillance at a time interval of 6 months, but the Japanese HCC guideline recommend the very-high risk patients undergoing ultrasound surveillance at a time interval of 3 or 4 months.
The incidence of HCC is 0.3%-0.8% in the chronic hepatitis B patients and 2%-8% in cirrhotic patients, thus recalling a different follow-up strategy for different stage of chronic hepatitis B patients. Besides, ultrasound is the admitted surveillance tool for HCC for its convenience and cost-effectiveness. However, the sensitivity of ultrasound detecting HCC will remarkably decrease because of the influence of ribs, pulmonary and gastrointestinal gas, cirrhosis and fatty liver. So it is necessary to incorporate computed tomography (CT) or magnetic resonance imaging (MRI) into the follow-up strategy of very high risk patient such as patients with cirrhosis or history of HCC.
The aim of this study is to investigate whether different surveillance time intervals and surveillance methods are beneficial for chronic hepatitis B and cirrhotic patients with different risk of HCC, ultimately establish an all-round and convenient follow-up strategy of Chronic Hepatitis B for early detection and diagnosis of HCC.
- Conditions
- Chronic Hepatitis B
- Being tested
- 3 months, 6 months, 3 month ultrasound(US)+3 month CT/MRI+3 month US+3 month CT/MRI
- Keywords
- surveillance, hepatocellular carcinoma, ultrasound, cirrhosis, chronic hepatitis B
- Medical subject headings
- Hepatitis B, Chronic, Carcinoma, Hepatocellular, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 monthsOther
6 monthsOther
3 month ultrasound(US)+3 month CT/MRI+3 month US+3 month CT/MRIOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Chronic Hepatitis B patient Receives: Other: 3 months | |
| 2 | Chronic Hepatitis B patient Receives: Other: 6 months | |
| 3 | cirrhotic patient Receives: Other: 3 months | |
| 4 | cirrhotic patient Receives: Other: 6 months | |
| 5 | ultrasound-difficult patient Receives: Other: 3 month ultrasound(US)+3 month CT/MRI+3 month US+3 month CT/MRI | |
| 6 | ultrasound-difficult patient Receives: Other: 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of Hepatocellular carcinoma
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2020 (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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rongqin Zheng, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- zhongzhen zz Su, doctor, Study director, The department of Ultrasound, the third affiliated hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817685
- Sponsor's protocol ID
- SYSU2016
- Status last verified
- Jun 2016
- First submitted
- 27 Jun 2016
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Strategy of Chronic Hepatitis B for Early Detection and Diagnosis of Hepatocellular Carcinoma: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02817685
- Acronym / sponsor ID
- SYSU2016
- Conditions
- Chronic Hepatitis B
- Keywords
- surveillance, hepatocellular carcinoma, ultrasound, cirrhosis, chronic hepatitis B
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7,660 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2020 (estimated)
- First posted
- 29 Jun 2016 (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 study is a randomized control prospective study. The aim of this study is to establish an all-round and convenient follow-up strategy of Chronic Hepatitis B for early detection and diagnosis of Hepatocellular Carcinoma (HCC), by investigating whether different surveillance time intervals and surveillance methods are beneficial for chronic hepatitis B and cirrhotic patients with different risk of HCC.
Detailed description
Surveillance of chronic hepatitis B and cirrhotic patients had been demonstrated to increase chances of curative treatment for hepatocellular carcinoma. However, the optimal surveillance interval for different risk patients is still controversial. The AASLD and EASL-EORTC guidelines recommend chronic hepatitis B patients undergoing ultrasound surveillance at a time interval of 6 months, but the Japanese HCC guideline recommend the very-high risk patients undergoing ultrasound surveillance at a time interval of 3 or 4 months.
The incidence of HCC is 0.3%-0.8% in the chronic hepatitis B patients and 2%-8% in cirrhotic patients, thus recalling a different follow-up strategy for different stage of chronic hepatitis B patients. Besides, ultrasound is the admitted surveillance tool for HCC for its convenience and cost-effectiveness. However, the sensitivity of ultrasound detecting HCC will remarkably decrease because of the influence of ribs, pulmonary and gastrointestinal gas, cirrhosis and fatty liver. So it is necessary to incorporate computed tomography (CT) or magnetic resonance imaging (MRI) into the follow-up strategy of very high risk patient such as patients with cirrhosis or history of HCC.
The aim of this study is to investigate whether different surveillance time intervals and surveillance methods are beneficial for chronic hepatitis B and cirrhotic patients with different risk of HCC, ultimately establish an all-round and convenient follow-up strategy of Chronic Hepatitis B for early detection and diagnosis of HCC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: 3 monthsChronic Hepatitis B patient |
| 2 | – | Other: 6 monthsChronic Hepatitis B patient |
| 3 | – | Other: 3 monthscirrhotic patient |
| 4 | – | Other: 6 monthscirrhotic patient |
| 5 | – | Other: 3 month ultrasound(US)+3 month CT/MRI+3 month US+3 month CT/MRIultrasound-difficult patient |
| 6 | – | Other: 6 monthsultrasound-difficult patient |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic Hepatitis B patients
Key inclusion criteria (2 listed)
- HBV-Ag positive( >6 months)
- age among 18 and 80 years
Key exclusion criteria (7 listed)
- patients with hepatocellular carcinoma
- patients were diagnosis hepatocellular carcinoma within 3 months of inclusion;
- patients with alcoholic hepatitis or autoimmune hepatitis
- patients with severe uncontrolled disease resulting in estimated life expectance less than 1 year
- coinfection with human immunodeficiency virus(HIV)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 months | Other | 1, 3 |
| 6 months | Other | 2, 4, 6 |
| 3 month ultrasound(US)+3 month CT/MRI+3 month US+3 month CT/MRI | Other | 5 |
Primary outcome
The incidence of Hepatocellular carcinoma
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
- Individual participant dataSharing planned: No
Related trials for Chronic Hepatitis B
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Chronic Hepatitis B
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.
zhongzhen zz Su, doctor study director
The department of Ultrasound, the third affiliated hospital of Sun Yat-sen University
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, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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 7 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 29 Jun 2016. 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 China. 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 zhongzhen zz Su, doctor (0086-020-85252010, sp9313@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of Hepatocellular carcinoma (time frame: 3 year). 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 29 Jun 2016.