Hepatocellular CarcinomaNCT00764140
Tumor Growth Factors in Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Malignant cells frequently produce many tumor growth factors to autocidal or endocrinal proliferate growth, metastasis,or angiogenesis about tumor cells. By studying tumor growth factors in hepatocellular carcinoma, one may know the tumor behavior, its relationship with clinical manifestation or invasion, and could be… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- tumor growth factor concentration
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2007to Apr 2010
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with aspiration cytology or biopsy proved HCC and sex- and age-matched healthy controls.
Who may be able to join
- Histology proven HCC
Who cannot join
- No definitely diagnosed tumor
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Kaohsiung, 807
About this study
Official title: Insulin-like Growth Factors (IGF) Axis (IGFs, Its Binding Proteins,Receptors), Transforming Growth Factor Alpha and Beta 1 and Epidermal Growth Factor in the Urine and Serum of Patients With Hepatocellular Carcinoma.
Malignant cells frequently produce many tumor growth factors to autocidal or endocrinal proliferate growth, metastasis,or angiogenesis about tumor cells. By studying tumor growth factors in hepatocellular carcinoma, one may know the tumor behavior, its relationship with clinical manifestation or invasion, and could be used as diagnostic or prognostic tools.This study aims to study the relationship between tumor growth factors in HCC ant its clinical relevance.
Read the detailed description
The clinical relevance of patients will be evaluated by the concentrations of tumor growth factors.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- tumor growth factor concentration
- Keywords
- tumor growth factor
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tumor growth factor concentrationBiological
Also called urine concentration of tumor growth factor, serum concentration of tumor growth factor
spot urine or blood collection will be used to measure specific tumor growth factor
| Study group | Role | What they receive |
|---|---|---|
| 2 | Specific tumor growth factors (IGFs, its binding proteins,receptors; transforming growth factor alpha and beta 1 and epidermal growth factor) in the urine and serum will be measured in patients with hepatocellular carcinoma and healthy controls | |
| 1 | Patients with hepatocellular carcinoma and Healthy controls Receives: Biological: tumor growth factor concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: 5 years
Secondary outcomes (1)
distant metastasis
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startJan 2007
- Primary completionApr 2010
- Study completionApr 2010
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-control
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Fa,Tsai, Kaohsiung Medical University Chung-Ho Memorial Hospital
- Investigators
- Jung-Fa Tsai, M.D., Ph.D., Principal investigator, Professor of Medine, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764140
- Sponsor's protocol ID
- KMUH-IRB-960010
- Status last verified
- Apr 2013
- First submitted
- 26 Feb 2008
- Last updated
- 18 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin-like Growth Factors (IGF) Axis (IGFs, Its Binding Proteins,Receptors), Transforming Growth Factor Alpha and Beta 1 and Epidermal Growth Factor in the Urine and Serum of Patients With Hepatocellular Carcinoma.
- ClinicalTrials.gov ID
- NCT00764140
- Acronym / sponsor ID
- KMUH-IRB-960010
- Conditions
- Hepatocellular Carcinoma
- Keywords
- tumor growth factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 1 Oct 2008 (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.
Malignant cells frequently produce many tumor growth factors to autocidal or endocrinal proliferate growth, metastasis,or angiogenesis about tumor cells. By studying tumor growth factors in hepatocellular carcinoma, one may know the tumor behavior, its relationship with clinical manifestation or invasion, and could be used as diagnostic or prognostic tools.This study aims to study the relationship between tumor growth factors in HCC ant its clinical relevance.
Detailed description
The clinical relevance of patients will be evaluated by the concentrations of tumor growth factors.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | – | –Specific tumor growth factors (IGFs, its binding proteins,receptors; transforming growth factor alpha and beta 1 and epidermal growth factor) in the urine and serum will be measured in patients with hepatocellular carcinoma and healthy controls |
| 1 | – | Biological: tumor growth factor concentrationPatients with hepatocellular carcinoma and Healthy controls |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with aspiration cytology or biopsy proved HCC and sex- and age-matched healthy controls.
Key inclusion criteria (1 listed)
- Histology proven HCC
Key exclusion criteria (1 listed)
- No definitely diagnosed tumor
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 |
|---|---|---|
| tumor growth factor concentrationAlso: urine concentration of tumor growth factor, serum concentration of tumor growth factorspot urine or blood collection will be used to measure specific tumor growth factor | Biological | 1 |
Primary outcome
mortality
Time frame: 5 years
1 secondary outcome
distant metastasis
Time frame: 5 years
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 18 Apr 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.
Jung-Fa Tsai, M.D., Ph.D. principal investigator
Professor of Medine, 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 18 Apr 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 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?
mortality (time frame: 5 years). 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 18 Apr 2013.