Carcinoma, HepatocellularNCT00397540
The Effect of Viral Load on Intrahepatic Recurrence in Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (HCC)
A study testing PEIT and RFTA in people with Carcinoma, Hepatocellular and Chronic Hepatitis B, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the effect of serum hepatitis B virus (HBV) DNA level on intrahepatic recurrence in locally treatable hepatocellular carcinomas (HCCs) related with HBV. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Carcinoma, Hepatocellular, Chronic Hepatitis B
- What is being tested?
- PEIT and RFTA
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2004to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Child-Pugh Class A or B
- Maximal tumor size less than 5 cm
- No previous history of treatment for hepatocellular carcinoma
- Recurrent hepatocellular carcinoma located more than 2 cm from the previous cancer site and is found more than 1 year's gap
Who cannot join
- Hepatocellular carcinoma in portal vein
- Hepatocellular carcinoma in hepatic vein
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Cohort Study of the Effect of Serum HBV DNA Level on Intrahepatic Recurrence in Locally Treatable, HBV-related HCC Patients
The purpose of this study is to evaluate the effect of serum hepatitis B virus (HBV) DNA level on intrahepatic recurrence in locally treatable hepatocellular carcinomas (HCCs) related with HBV.
Read the detailed description
Prospective cohort study
Survival
- Overall survival rate
- Disease free survival rate
Recurrence
- Cumulative recurrence rate
- Conditions
- Carcinoma, Hepatocellular, Chronic Hepatitis B
- Being tested
- PEIT, RFTA
- Keywords
- HBV DNA, HCC, recurrence, PEIT, RFTA
- Medical subject headings
- Carcinoma, Hepatocellular, Hepatitis B, Chronic, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEITProcedure or surgery
Also called PEI, local ablation therapy
Percutaneous Ethanol Injection Therapy
RFTAProcedure or surgery
Also called RFA, local ablation therapy
Radiofrequency Thermal Ablation
| Study group | Role | What they receive |
|---|---|---|
| percutaneous ethanol injection therapy | Active comparator | Patients with hepatocellular carcinoma who will be treated with PEIT (percutaneous ethanol injection therapy) Receives: Procedure: PEIT |
| radiofrequency thermal ablation | Active comparator | Patients with hepatocellular carcinoma who will be treated with RFTA (radiofrequency thermal ablation) Receives: Procedure: RFTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
1,3,5 Year-Disease Free Survival (or Recurrence Free Survival)
The disease free survival is defined as the total number of surviving participants without intrahepatic recurrence of hepatocellular carcinoma for 1, 3, and 5 years.
Measured: 1,3,5 year
Secondary outcomes (1)
Overall Survival
Overall Survival: Number of Participants who Died
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2006 (estimated)
- Study startOct 2004
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Hwan Yoon, Seoul National University Hospital
- Investigators
- Won Kim, Professor, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00397540
- Sponsor's protocol ID
- 10-2006-001
- Status last verified
- Mar 2019
- First submitted
- 7 Nov 2006
- Last updated
- 18 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Seo JY, Kim W, Kwon JH, Jin EH, Yu SJ, Kim HY, Jung YJ, Kim D, Kim YJ, Yoon JH, Lee HS. Noninvasive fibrosis indices predict intrahepatic distant recurrence of hepatitis B-related hepatocellular carcinoma following radiofrequency ablation. Liver Int. 2013 Jul;33(6):884-93. doi: 10.1111/liv.12132. Epub 2013 Mar 5.
PubMed 23461618Chung GE, Kim W, Lee JH, Kim YJ, Yoon JH, Lee JM, Lee JY, Kim SH, Kim D, Lee HS. Negative hepatitis B envelope antigen predicts intrahepatic recurrence in hepatitis B virus-related hepatocellular carcinoma after ablation therapy. J Gastroenterol Hepatol. 2011 Nov;26(11):1638-45. doi: 10.1111/j.1440-1746.2011.06777.x.
PubMed 22011297
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of the Effect of Serum HBV DNA Level on Intrahepatic Recurrence in Locally Treatable, HBV-related HCC Patients
- ClinicalTrials.gov ID
- NCT00397540
- Acronym / sponsor ID
- 10-2006-001
- Conditions
- Carcinoma, Hepatocellular, Chronic Hepatitis B
- Keywords
- HBV DNA, HCC, recurrence, PEIT, RFTA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 9 Nov 2006 (estimated)
- Results
- Posted 15 Mar 2010
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 evaluate the effect of serum hepatitis B virus (HBV) DNA level on intrahepatic recurrence in locally treatable hepatocellular carcinomas (HCCs) related with HBV.
Detailed description
Prospective cohort study
Survival
- Overall survival rate
- Disease free survival rate
Recurrence
- Cumulative recurrence rate
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| percutaneous ethanol injection therapy | Active comparator | Procedure: PEITPatients with hepatocellular carcinoma who will be treated with PEIT (percutaneous ethanol injection therapy) |
| radiofrequency thermal ablation | Active comparator | Procedure: RFTAPatients with hepatocellular carcinoma who will be treated with RFTA (radiofrequency thermal ablation) |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Child-Pugh Class A or B
- Maximal tumor size less than 5 cm
- No previous history of treatment for hepatocellular carcinoma
- Recurrent hepatocellular carcinoma located more than 2 cm from the previous cancer site and is found more than 1 year's gap
Key exclusion criteria (2 listed)
- Hepatocellular carcinoma in portal vein
- Hepatocellular carcinoma in hepatic vein
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 |
|---|---|---|
| PEITAlso: PEI, local ablation therapyPercutaneous Ethanol Injection Therapy | Procedure or surgery | percutaneous ethanol injection therapy |
| RFTAAlso: RFA, local ablation therapyRadiofrequency Thermal Ablation | Procedure or surgery | radiofrequency thermal ablation |
Primary outcome
1,3,5 Year-Disease Free Survival (or Recurrence Free Survival)
Time frame: 1,3,5 year
The disease free survival is defined as the total number of surviving participants without intrahepatic recurrence of hepatocellular carcinoma for 1, 3, and 5 years.
1 secondary outcome
Overall Survival
Time frame: through study completion, an average of 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23461618Seo JY, Kim W, Kwon JH, Jin EH, Yu SJ, Kim HY, Jung YJ, Kim D, Kim YJ, Yoon JH, Lee HS. Noninvasive fibrosis indices predict intrahepatic distant recurrence of hepatitis B-related hepatocellular carcinoma following radiofrequency ablation. Liver Int. 2013 Jul;33(6):884-93. doi: 10.1111/liv.12132. Epub 2013 Mar 5.
- Derived from this study: PubMed 22011297Chung GE, Kim W, Lee JH, Kim YJ, Yoon JH, Lee JM, Lee JY, Kim SH, Kim D, Lee HS. Negative hepatitis B envelope antigen predicts intrahepatic recurrence in hepatitis B virus-related hepatocellular carcinoma after ablation therapy. J Gastroenterol Hepatol. 2011 Nov;26(11):1638-45. doi: 10.1111/j.1440-1746.2011.06777.x.
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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.
Won Kim, Professor study director
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEIT and RFTA in people with Carcinoma, Hepatocellular and Chronic Hepatitis B, run by Seoul National University Hospital at 1 site in South Korea.
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 18 Mar 2019. 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 South Korea. 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?
Yes. Results are posted in the registry (first posted 15 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
1,3,5 Year-Disease Free Survival (or Recurrence Free Survival) (time frame: 1,3,5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00397540, which also lists 2 linked publications.
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 18 Mar 2019.