Carcinoma, HepatocellularNCT01237132
East-West Hepatocellular Carcinoma Study Group
An observational study of Carcinoma, Hepatocellular, run by University of Milan.
Trial summary
The current treatment guidelines of hepatocellular carcinoma (HCC) of the American and European Associations for the Study of Liver Disease are based on the Barcelona-Clinic-Liver-Cancer classification (BCLC), which does not recommend surgery in patients with large, multinodular and macrovascular invasive disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carcinoma, Hepatocellular
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients affected by HCC
Who may be able to join
- clinical diagnosis of hepatocellular carcinoma
- candidate to liver resection as a curative treatment
Who cannot join
- uncertain diagnosis of hepatocellular carcinoma
- uncertain follow-up data
About this study
Official title: EAST-WEST HEPATOCELLULAR CARCINOMA STUDY GROUP
The current treatment guidelines of hepatocellular carcinoma (HCC) of the American and European Associations for the Study of Liver Disease are based on the Barcelona-Clinic-Liver-Cancer classification (BCLC), which does not recommend surgery in patients with large, multinodular and macrovascular invasive disease. The aim of this study was to investigate the role of hepatic resection in a large retrospective multicentric cohort of patients resected for HCC regardless of the BCLC indications.
- Conditions
- Carcinoma, Hepatocellular
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival of resected patients for HCC
The primary endpoint of the study was the overall survival of patients resected for HCC in any stage of the BCLC classification.
Secondary outcomes (1)
Disease-free survival of resected patients for HCC
The secondary endpoint was the disease-free survival of patients resected for HCC among the BCLC stages.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies 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
- Retrospective
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237132
- Sponsor's protocol ID
- HCC EWE
- Status last verified
- Dec 2009
- First submitted
- 8 Nov 2010
- Last updated
- 9 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EAST-WEST HEPATOCELLULAR CARCINOMA STUDY GROUP
- ClinicalTrials.gov ID
- NCT01237132
- Acronym / sponsor ID
- HCC EWE
- Conditions
- Carcinoma, Hepatocellular
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of MilanUniversity, hospital or other
- First posted
- 9 Nov 2010 (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 current treatment guidelines of hepatocellular carcinoma (HCC) of the American and European Associations for the Study of Liver Disease are based on the Barcelona-Clinic-Liver-Cancer classification (BCLC), which does not recommend surgery in patients with large, multinodular and macrovascular invasive disease. The aim of this study was to investigate the role of hepatic resection in a large retrospective multicentric cohort of patients resected for HCC regardless of the BCLC indications.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients affected by HCC
Key inclusion criteria (2 listed)
- clinical diagnosis of hepatocellular carcinoma
- candidate to liver resection as a curative treatment
Key exclusion criteria (2 listed)
- uncertain diagnosis of hepatocellular carcinoma
- uncertain follow-up data
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
Overall survival of resected patients for HCC
The primary endpoint of the study was the overall survival of patients resected for HCC in any stage of the BCLC classification.
1 secondary outcome
Disease-free survival of resected patients for HCC
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 9 Nov 2010.
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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 Carcinoma, Hepatocellular, run by University of Milan.
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 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 9 Nov 2010. 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.
What does the primary outcome measure?
Overall survival of resected patients for HCC. 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 9 Nov 2010.