Hepatocellular CarcinomaNCT00834028
Recurrence and Distant Metastases in Hepatocellular Carcinoma Treated by Transcatheter Arterial Chemoembolization
An observational study of Hepatocellular Carcinoma, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
This project will include at least 40 patients with hepatocellular carcinoma (HCC) who will receive transcatheter arterial chemoembolization (TACE) as a sole method for the management. The serum is collected before and at the 3rd and 7th day after TACE. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2007to Dec 2008
- 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 with hepatocellular carcinoma
Who may be able to join
- patients with hepatocellular carcinoma treated by transcatheter arterial chemoembolization
Who cannot join
- patients with hepatocellular carcinoma unable to be treated by transcatheter arterial chemoembolization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recurrence and Distant Metastases in Hepatocellular Carcinoma Treated by Transcatheter Arterial Chemoembolization : The Roles of VEGF, Cathepsin L, Endostatin, and Angiopoietin-2.
This project will include at least 40 patients with hepatocellular carcinoma (HCC) who will receive transcatheter arterial chemoembolization (TACE) as a sole method for the management. The serum is collected before and at the 3rd and 7th day after TACE. The serum levels of vascular endothelial growth factor, angiopoietin 2, endostatin and cathepsin L are determined. All patients will be evaluated according to the TNM system for the cancer staging before and 3 months after each session of treatment. The vascularity of tumor, the drug and the dose used for embolization, and the area of infarction will be recorded. These data will be compared with the clinical courses of the patients to obtain the most suitable way in the management of these patients.
Read the detailed description
Transcatheter arterial chemoembolization (TACE) is the traditional method for the palliative management of patients with hepatocellular carcinoma (HCC). This method will cause tissue hypoxia in area of embolization. Several proangiogenic factors will be induced by the condition of hypoxia. This may have the possibility to promote the proliferation of the residual cancer cells. However, there is no study to clarify this issue. This project will determine the serial changes of serum proangiogenic factors (vascular endothelial growth factor, angiopoietin 2), antiangiogenic factor (endostatin) and cathepsin L before and after TACE. These data will be compared with the clinical courses of the patients to obtain the most suitable way in the management of these patients.
This project will include at least 40 patients with HCC who will receive TACE as a sole method for the management. The serum is collected before and at the 3rd and 7th day after TACE. The serum levels of vascular endothelial growth factor, angiopoietin 2, endostatin and cathepsin L are determined. All patients will be evaluated according to the TNM system for the cancer staging before and 3 months after each session of treatment. The vascularity of tumor, the drug and the dose used for embolization, and the area of infarction will be recorded.
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma, vascular endothelial growth factor, angiopoietin, cathepsin
- 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 |
|---|---|---|
| 1 | patients with hepatocellular carcinoma receive transcatheter arterial chemoembolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor progression
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startFeb 2007
- Primary completionDec 2008
- Study completionDec 2008
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 Kaohsiung Medical University Chung-Ho Memorial 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- zu y lin, Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834028
- Sponsor's protocol ID
- KMUH-IRB-950168
- Status last verified
- Nov 2006
- First submitted
- 1 Feb 2009
- Last updated
- 3 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrence and Distant Metastases in Hepatocellular Carcinoma Treated by Transcatheter Arterial Chemoembolization : The Roles of VEGF, Cathepsin L, Endostatin, and Angiopoietin-2.
- ClinicalTrials.gov ID
- NCT00834028
- Acronym / sponsor ID
- KMUH-IRB-950168
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma, vascular endothelial growth factor, angiopoietin, cathepsin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 3 Feb 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.
This project will include at least 40 patients with hepatocellular carcinoma (HCC) who will receive transcatheter arterial chemoembolization (TACE) as a sole method for the management. The serum is collected before and at the 3rd and 7th day after TACE. The serum levels of vascular endothelial growth factor, angiopoietin 2, endostatin and cathepsin L are determined. All patients will be evaluated according to the TNM system for the cancer staging before and 3 months after each session of treatment. The vascularity of tumor, the drug and the dose used for embolization, and the area of infarction will be recorded. These data will be compared with the clinical courses of the patients to obtain the most suitable way in the management of these patients.
Detailed description
Transcatheter arterial chemoembolization (TACE) is the traditional method for the palliative management of patients with hepatocellular carcinoma (HCC). This method will cause tissue hypoxia in area of embolization. Several proangiogenic factors will be induced by the condition of hypoxia. This may have the possibility to promote the proliferation of the residual cancer cells. However, there is no study to clarify this issue. This project will determine the serial changes of serum proangiogenic factors (vascular endothelial growth factor, angiopoietin 2), antiangiogenic factor (endostatin) and cathepsin L before and after TACE. These data will be compared with the clinical courses of the patients to obtain the most suitable way in the management of these patients.
This project will include at least 40 patients with HCC who will receive TACE as a sole method for the management. The serum is collected before and at the 3rd and 7th day after TACE. The serum levels of vascular endothelial growth factor, angiopoietin 2, endostatin and cathepsin L are determined. All patients will be evaluated according to the TNM system for the cancer staging before and 3 months after each session of treatment. The vascularity of tumor, the drug and the dose used for embolization, and the area of infarction will be recorded.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –patients with hepatocellular carcinoma receive transcatheter arterial chemoembolization |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with hepatocellular carcinoma
Key inclusion criteria (1 listed)
- patients with hepatocellular carcinoma treated by transcatheter arterial chemoembolization
Key exclusion criteria (1 listed)
- patients with hepatocellular carcinoma unable to be treated by transcatheter arterial chemoembolization
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
tumor progression
Time frame: 12 months
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 Feb 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.
zu y lin principal investigator
Kaohsiung Medical 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 Hepatocellular Carcinoma, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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 Feb 2009. 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 Taiwan. 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?
tumor progression (time frame: 12 months). 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 3 Feb 2009.