Hepatocellular CarcinomaNCT00154544
Searching for the Liver Cancer-Related Biomarkers
An observational study of Hepatocellular Carcinoma, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Hepatocellular carcinoma (HCC) has been the leading cause of cancer death in Taiwan. About 6000-8000 people died of this cancer every year in Taiwan. Though regular sonographic examination can early detect small HCC and there are many therapeutic modalities for HCC, the therapeutic results remains unsatisfactory. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2004to 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- hepatocellular carcinoma
Who cannot join
- multiple cancers
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Chien-Hung Chen, MD, 886-2-23123456 ext. 5923, chenhcc@ntumc.org
About this study
Official title: Identification of Biomarkers Associated With Human Hepatocellular Carcinoma by PROTEOMEX
Hepatocellular carcinoma (HCC) has been the leading cause of cancer death in Taiwan. About 6000-8000 people died of this cancer every year in Taiwan. Though regular sonographic examination can early detect small HCC and there are many therapeutic modalities for HCC, the therapeutic results remains unsatisfactory. Though Alpha-fetoprotein (AFP) and des-γ-carboxy prothrombin (DCP) are used as the tumor markers for diagnosis of HCCs, these two markers are not good enough for the early detection of small HCCs. To improve the survival, further investigations of the early diagnostic markers are still needed. In this current project, we applied the proteomic method to identify the HCC biomarkers.
Read the detailed description
Cell lines Hep3B and Huh7 HCC cell lines will be cultured in (Dulbecco's modified Eagle medium) DMEM containing 10% fetal calf serum and incubated at 37 C in 5% CO2 incubator. The rationale of using HCC cell line instead of clinical HCC samples is that HCC tissues are heterogeneous and might contain some non-HCC cells. The cell will be harvested when cells reach 95% confluence.
Sera collection 20 mL of venous 20 mL of venous blood was collected from 20 HBV-related HCC and 20 HCV-related HCC patients before treatment. The venous blood was allowed to clot, centrifuged at 800 g for 5 min, and serum was aliquoted and stored at -80 0C. Control sera were obtained from 20 HBV carriers without HCC, 20 chronic hepatitis C patients without HCC, and 10 normal subjects without liver diseases.
Two-dimensional gel electrophoresis using patients' sera for immunoblotting will be done. Spots of interest will be identified by delayed extraction matrix-assisted laser desorption ionization.
- Conditions
- Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startAug 2004
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 National Taiwan University 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
- Defined population
- Time perspective
- Other
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chien-Hung Chen, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154544
- Sponsor's protocol ID
- 9261701419
- Other IDs
- NSC 93-2314-B-002-228
- Status last verified
- Dec 2003
- First submitted
- 9 Sep 2005
- Last updated
- 20 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Biomarkers Associated With Human Hepatocellular Carcinoma by PROTEOMEX
- ClinicalTrials.gov ID
- NCT00154544
- Acronym / sponsor ID
- 9261701419
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2004
- First posted
- 12 Sep 2005 (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.
Hepatocellular carcinoma (HCC) has been the leading cause of cancer death in Taiwan. About 6000-8000 people died of this cancer every year in Taiwan. Though regular sonographic examination can early detect small HCC and there are many therapeutic modalities for HCC, the therapeutic results remains unsatisfactory. Though Alpha-fetoprotein (AFP) and des-γ-carboxy prothrombin (DCP) are used as the tumor markers for diagnosis of HCCs, these two markers are not good enough for the early detection of small HCCs. To improve the survival, further investigations of the early diagnostic markers are still needed. In this current project, we applied the proteomic method to identify the HCC biomarkers.
Detailed description
Cell lines Hep3B and Huh7 HCC cell lines will be cultured in (Dulbecco's modified Eagle medium) DMEM containing 10% fetal calf serum and incubated at 37 C in 5% CO2 incubator. The rationale of using HCC cell line instead of clinical HCC samples is that HCC tissues are heterogeneous and might contain some non-HCC cells. The cell will be harvested when cells reach 95% confluence.
Sera collection 20 mL of venous 20 mL of venous blood was collected from 20 HBV-related HCC and 20 HCV-related HCC patients before treatment. The venous blood was allowed to clot, centrifuged at 800 g for 5 min, and serum was aliquoted and stored at -80 0C. Control sera were obtained from 20 HBV carriers without HCC, 20 chronic hepatitis C patients without HCC, and 10 normal subjects without liver diseases.
Two-dimensional gel electrophoresis using patients' sera for immunoblotting will be done. Spots of interest will be identified by delayed extraction matrix-assisted laser desorption ionization.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- hepatocellular carcinoma
Key exclusion criteria (1 listed)
- multiple cancers
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2005.
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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.
Chien-Hung Chen, MD principal investigator
National Taiwan University Hospital
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 National Taiwan University 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: status not confirmed, as of the sponsor's last update on 20 Dec 2005. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chien-Hung Chen, MD (886-2-23123456 ext. 5923, chenhcc@ntumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 20 Dec 2005.