Hepatocellular CarcinomaHSP70NCT00769535
Relationship Between Polymorphism of Heat Shock Protein 70 Gene and Hepatocellular Carcinoma
A study testing Polymorphisms of HSP70 and TNF promoter in people with Hepatocellular Carcinoma, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 2 sites in Taiwan.
Trial summary
Polymorphisms of HSP70 and tumor necrosis factor-alpha promoter in patients with hepatocellular carcinoma, chronic liver disease and healthy controls will be measured by PCR-RFLP or direct sequencing. The clinical relevance of patients will be compared in those with polymorphism and those without. 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?
- Polymorphisms of HSP70 and TNF promoter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesTaiwan
- Study dates
- Jan 2006to Jun 2008
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- History proven HCC patients
Who cannot join
- No-definite diagnosed patients
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Kaohsiung Medical University
Kaohsiung City, Kaohsiung, 807
Kaohsiung Medical University
Kaohsiung City, Kaohsiun, 807
About this study
Polymorphisms of HSP70 and tumor necrosis factor-alpha promoter in patients with hepatocellular carcinoma, chronic liver disease and healthy controls will be measured by PCR-RFLP or direct sequencing. The clinical relevance of patients will be compared in those with polymorphism and those without.
Read the detailed description
Heat shock protein 70 (HSP 70) may be involved in various aspects of immune system including infection, autoimmunity, and tumor immunity. The relationship between HSP70 expression, disease activity and cancer prognosis varied according to type of cancer. The overexpression of HSP70 by tumor cells contributes to tumor behavior. HSP70 is present in normal and abnormal hepatocytes, and was reported to be over-expressed in both hepatoma cell lines and human hepatocellular carcinoma (HCC) tissue. Recent study indicated that HSP70 is a molecular marker during early hepatocarcinogenesis. It is also involved in anti-tumor immunity in HCC.We also investigate the polymorphism of tumor necrosis factor-alpha promoter, and correlated to clinical relevance.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Polymorphisms of HSP70 and TNF promoter
- Keywords
- heat shock protein70, tumor necrosis factor-alpha promoter, polymorphism
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polymorphisms of HSP70 and TNF promoterGenetic
Also called polymorphism of HSP70, polymorphism of tumor necrosis factor-alpha promoter
To assess the relationship between clinical relevance and polymorphisms of HSP70 and tumor necrosis factor-alpha with PCR_RFLP
| Study group | Role | What they receive |
|---|---|---|
| HSP70 and TNF polymorphisms | Experimental | Not described Receives: Genetic: Polymorphisms of HSP70 and TNF promoter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical relevance
Measured: year
Secondary outcomes (1)
Clinical relevance
Measured: year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study startJan 2006
- Primary completionJun 2008
- Study completionJun 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jung-Fa Tsai, M.D., Ph.D., Principal investigator, Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769535
- Sponsor's protocol ID
- KMUH-IRB-930047
- Acronym
- HSP70
- Status last verified
- Apr 2013
- First submitted
- 26 Feb 2008
- Last updated
- 30 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Polymorphism of Heat Shock Protein 70 Gene and Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00769535
- Acronym / sponsor ID
- HSP70 / KMUH-IRB-930047
- Conditions
- Hepatocellular Carcinoma
- Keywords
- heat shock protein70, tumor necrosis factor-alpha promoter, polymorphism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 9 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.
Polymorphisms of HSP70 and tumor necrosis factor-alpha promoter in patients with hepatocellular carcinoma, chronic liver disease and healthy controls will be measured by PCR-RFLP or direct sequencing. The clinical relevance of patients will be compared in those with polymorphism and those without.
Detailed description
Heat shock protein 70 (HSP 70) may be involved in various aspects of immune system including infection, autoimmunity, and tumor immunity. The relationship between HSP70 expression, disease activity and cancer prognosis varied according to type of cancer. The overexpression of HSP70 by tumor cells contributes to tumor behavior. HSP70 is present in normal and abnormal hepatocytes, and was reported to be over-expressed in both hepatoma cell lines and human hepatocellular carcinoma (HCC) tissue. Recent study indicated that HSP70 is a molecular marker during early hepatocarcinogenesis. It is also involved in anti-tumor immunity in HCC.We also investigate the polymorphism of tumor necrosis factor-alpha promoter, and correlated to clinical relevance.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HSP70 and TNF polymorphisms | Experimental | Genetic: Polymorphisms of HSP70 and TNF promoter |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- History proven HCC patients
Key exclusion criteria (1 listed)
- No-definite diagnosed patients
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 |
|---|---|---|
| Polymorphisms of HSP70 and TNF promoterAlso: polymorphism of HSP70, polymorphism of tumor necrosis factor-alpha promoterTo assess the relationship between clinical relevance and polymorphisms of HSP70 and tumor necrosis factor-alpha with PCR_RFLP | Genetic | HSP70 and TNF polymorphisms |
Primary outcome
Clinical relevance
Time frame: year
1 secondary outcome
Clinical relevance
Time frame: 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 30 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 Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polymorphisms of HSP70 and TNF promoter in people with Hepatocellular Carcinoma, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 2 sites 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 30 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 2 sites 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?
Clinical relevance (time frame: 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 30 Apr 2013; AzTrials last refreshed its copy on 7 Nov 2026.