Hepatocellular CarcinomaNCT01520779
Recurrence of Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma, run by Ain Shams University at 1 site in Egypt.
Trial summary
analysis of the risk factors of intra-hepatic distant recurrence (IDR) of hepatocellular carcinoma within 1 year after radiofrequency ablation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 99 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2012to Dec 2012
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hepatocellular carcinoma (HCC) who underwent radiofrequency ablation (RFA) from 1/2006 till 12/2010in Tropical medicine department and hepatocellular carcinoma clinic, Ain Shams university
Who may be able to join
- Proved diagnosis of HCC according to AASLD practice guidelines (Bruix and Sherman, 2005).
- Patients underwent RFA for HCC with BCLC (The Barcelona-Clinic- Liver-Cancer staging system) stage A (Bruix and Sherman, 2005) with no eligibility or ability to do transplantation or resection.
- Patients should be followed-up for more than 12 months to exclude early recurrence i.e. recurrence within 1 year.
- Patients with INR < 1.5 or prothrombin concentration > 50%.
- Platelet count > 50000 cell/mm3.
Who cannot join
- Presence of extra-hepatic metastasis or gross vascular invasion.
- Child class C patients.
- Follow up period of less than 12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factors for Recurrence of Hepatocellular Carcinoma After Radiofrequency Ablation
analysis of the risk factors of intra-hepatic distant recurrence (IDR) of hepatocellular carcinoma within 1 year after radiofrequency ablation.
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular cacinoma, Radiofrequancy ablation, Intrahepatic recurrence
- Medical subject headings
- Carcinoma, Hepatocellular
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 |
|---|---|---|
| Patients with recurrence | Hepatocellular carcinoma patients with intra-hepatic or distant recurrence of hepatocellular carcinoma within 1 year after radiofrequency ablation | |
| Patients with no recurrence | Hepatocellular carcinoma with no intra-hepatic or distant recurrence of hepatocellular carcinoma within 1 year after radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of hepatocellular carcinoma
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionNov 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iman Fawzy Montasser, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520779
- Sponsor's protocol ID
- HCC recurrence after RFA
- Status last verified
- Sep 2013
- First submitted
- 26 Jan 2012
- Last updated
- 1 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Recurrence of Hepatocellular Carcinoma After Radiofrequency Ablation
- ClinicalTrials.gov ID
- NCT01520779
- Acronym / sponsor ID
- HCC recurrence after RFA
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular cacinoma, Radiofrequancy ablation, Intrahepatic recurrence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Jan 2012 (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.
analysis of the risk factors of intra-hepatic distant recurrence (IDR) of hepatocellular carcinoma within 1 year after radiofrequency ablation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with recurrence | – | –Hepatocellular carcinoma patients with intra-hepatic or distant recurrence of hepatocellular carcinoma within 1 year after radiofrequency ablation |
| Patients with no recurrence | – | –Hepatocellular carcinoma with no intra-hepatic or distant recurrence of hepatocellular carcinoma within 1 year after radiofrequency ablation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hepatocellular carcinoma (HCC) who underwent radiofrequency ablation (RFA) from 1/2006 till 12/2010in Tropical medicine department and hepatocellular carcinoma clinic, Ain Shams university
Key inclusion criteria (5 listed)
- Proved diagnosis of HCC according to AASLD practice guidelines (Bruix and Sherman, 2005).
- Patients underwent RFA for HCC with BCLC (The Barcelona-Clinic- Liver-Cancer staging system) stage A (Bruix and Sherman, 2005) with no eligibility or ability to do transplantation or resection.
- Patients should be followed-up for more than 12 months to exclude early recurrence i.e. recurrence within 1 year.
- Patients with INR < 1.5 or prothrombin concentration > 50%.
- Platelet count > 50000 cell/mm3.
Key exclusion criteria (3 listed)
- Presence of extra-hepatic metastasis or gross vascular invasion.
- Child class C patients.
- Follow up period of less than 12 months.
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
Recurrence of hepatocellular carcinoma
Time frame: 1 year
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 1 Oct 2013.
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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.
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 Hepatocellular Carcinoma, run by Ain Shams University at 1 site in Egypt.
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 5 inclusion and 3 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 1 Oct 2013. 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 Egypt. 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?
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.
What does the primary outcome measure?
Recurrence of hepatocellular carcinoma (time frame: 1 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 1 Oct 2013.