Carcinoma, HepatocellularNCT01177631
Proteomic Analysis of Human Hepatocellular Carcinoma
A study testing Operation in people with Carcinoma, Hepatocellular, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
This is a pilot study to evaluate the difference between the protein expression between hepatocellular carcinoma and tumor with vessel invasion in Asian patients with hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Operation
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2009to Jan 2010
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Arm A: Hepatocellular carcinoma with vessel invasion:
- hepatocellular carcionoma, pathologic diagnosed.
- image documented vessel invasion, including portal vein thrombosis
- eligible for surgical intervension.
- Arm B: hepatocellular carcinoma without vessel invasion:
- hepatocellular carcinoma, pathologic diagnosed or clinical diagnosed according to EASL criteria.
Show all 10Show fewer
- no vessel invasion on image.
- Arm C: Healthy hepatitis carrier:
- patients age >18 years old with hepatitis B or C
- normal liver function.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proteomic Analysis of Human Hepatocellular Carcinoma Associated With Portal Vein Thrombosis
This is a pilot study to evaluate the difference between the protein expression between hepatocellular carcinoma and tumor with vessel invasion in Asian patients with hepatocellular carcinoma.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Operation
- Keywords
- Carcinoma, hepatocellular, Portal vein, Proteomics
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OperationProcedure or surgery
Operation for clinically evaluated resectable hepatocelluar carcinoma. Compare the different expression of protein between tumor, non-tumor and tumor with vascular invasion part.
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Evidence of clinically definite vascular invasion of hepatocellular carcinoma. Confirmed by operation. Compare the proteomic expression of tumor, non-tumor ans tumor tissue in vascular part.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2010 (estimated)
- Study startFeb 2009
- Primary completionJan 2010
- Study completionJan 2010
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meng-Tzu Weng, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01177631
- Sponsor's protocol ID
- 97068
- Status last verified
- Feb 2016
- First submitted
- 2 Jun 2009
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomic Analysis of Human Hepatocellular Carcinoma Associated With Portal Vein Thrombosis
- ClinicalTrials.gov ID
- NCT01177631
- Acronym / sponsor ID
- 97068
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- Carcinoma, hepatocellular, Portal vein, Proteomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 9 Aug 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.
This is a pilot study to evaluate the difference between the protein expression between hepatocellular carcinoma and tumor with vessel invasion in Asian patients with hepatocellular carcinoma.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- hepatocellular carcionoma, pathologic diagnosed.
- image documented vessel invasion, including portal vein thrombosis
- eligible for surgical intervension.
- hepatocellular carcinoma, pathologic diagnosed or clinical diagnosed according to EASL criteria.
- no vessel invasion on image.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| OperationOperation for clinically evaluated resectable hepatocelluar carcinoma. Compare the different expression of protein between tumor, non-tumor and tumor with vascular invasion part. | Procedure or surgery | – |
Primary outcome
Recurrence
Time frame: one year
Evidence of clinically definite vascular invasion of hepatocellular carcinoma. Confirmed by operation. Compare the proteomic expression of tumor, non-tumor ans tumor tissue in vascular part.
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 5 Feb 2016.
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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?
A study testing Operation in people with Carcinoma, Hepatocellular, run by Far Eastern 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 10 inclusion and 0 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 5 Feb 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 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?
Recurrence (time frame: one 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 5 Feb 2016.