Hepatocellular CarcinomaNCT00154531
Identification of Biomarkers Associated With Human Hepatocellular Carcinoma by SELDI
An observational study of Hepatocellular Carcinoma and Hepatitis B, 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. Though Alpha-fetoprotein (AFP) and des-γ-carboxy prothrombin(DCP) are used as the tumor markers for diagnosis of HCCs. Thus, these two markers are not good enough for the early detection of small HCCs. Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma, Hepatitis B, Hepatitis C
- How many people
- 230 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2004to May 2005
- 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 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of hepatocellular carcinoma
- Clinical diagnosis of hepatitis B
- Clinical diagnosis of hepatitis C
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Jin-Chuan Sheu, M.D. Ph.D., 886-2-23123456 ext. 6579, sheuhcc@ha.mc.ntu.edu.tw
Chien-Hung Chen, M.D. PhD
About this study
Official title: Identification of Biomarkers Associated With Human Hepatocellular Carcinoma by Surface-Enhanced Laser Desorption/Ionization (SELDI)
Hepatocellular carcinoma (HCC) has been the leading cause of cancer death in Taiwan. Though Alpha-fetoprotein (AFP) and des-γ-carboxy prothrombin(DCP) are used as the tumor markers for diagnosis of HCCs. Thus, 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.
SELDI is a proteomic profiling techniques in biomarker discovery. Its approach has been successfully used to identify biomarkers of various cancers, such as prostate cancer, bladder cancer, ovarian cancer, lung cancer, colon cancer, breast cancer and pancreatic cancer.
In this current project we will apply the SELDI technique to identify the HCC biomarkers. Sera samples from the HCC patients and relevant controls will be collected. We hope that we can find the new HCC biomarkers. If biomarkers of HCC are identified, this can be used to clinical application for the possible early detection of HCCs.
Read the detailed description
Hepatocellular carcinoma (HCC) has been the leading cause of cancer death in Taiwan. Above 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, AFP is normal in around one third of small(<3cm) HCC patients. Elevated DCP activities were present in 44%-47.6% with HCCs less than 3cm. Thus, 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.
The global analysis of cellular proteins has recently been termed proteomics and is a key area if research that is developing in the postgenomic ear. With respect to cancer, proteomics has the potential to identify novel targets for therapy or markers for diagnosis. The proteomic profiling techniques in biomarker discovery include (1) 2-D PAGE / MALDI-MS (two-dimensional gel electrophoresis, polyacrylamide gel electrophoresis) / matrix assisted laser desorption / ionization-mass spectrometry), (2) LC/MS/MS (liquid chromatography/MS/MS), (3) SELDI-TOF (surface-enhanced laser desorption ionization time-of-flight). These techniques have their own advantages and shortcomings.
SELDI is a recently descried modification of MALDI-TOP in which small amounts of protein are directly applied to a biochip coated with specific chemical matrices (hydrophobic, cationic, anionic, normal phase, and so forth) or biochemical molecules such as DNA oligonucleotides or purified proteins. The bound proteins retained after washing are analyzed by mass spectrometry to obtain the protein fingerprint of the sample. The detected proteins are displayed as a series of peaks.
SELDI-TOF MS can offer high-throughput protein profiles. Blood, urine, body fluid, or tissue specimen are taken from the patients and then are applied onto different ProteinChip Arrays. The differences in the protein expression profiles of two or more distinct samples are thus obtained. SELDI approach has been successfully used to identify biomarkers of various cancers, such as prostate cancer, bladder cancer, ovarian cancer, lung cancer, colon cancer, breast cancer and pancreatic cancer.
In this current project we will apply the SELDI technique to identify the HCC biomarkers. Sera samples from the HCC patients and relevant controls will be collected. The samples will then be applied to SELDI analysis. We hope that we can find the new HCC biomarkers. If biomarkers of HCC are identified, this can be used to clinical application for the possible early detection of HCCs.
- Conditions
- Hepatocellular Carcinoma, Hepatitis B, Hepatitis C
- Medical subject headings
- Carcinoma, Hepatocellular, Hepatitis B, Hepatitis C
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
- Study completionMay 2005
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
- Case-control
- Time perspective
- Other
- Enrolment
- 230 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jin-Chuan Sheu, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154531
- Sponsor's protocol ID
- 9261701418
- 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 Surface-Enhanced Laser Desorption/Ionization (SELDI)
- ClinicalTrials.gov ID
- NCT00154531
- Acronym / sponsor ID
- 9261701418
- Conditions
- Hepatocellular Carcinoma, Hepatitis B, Hepatitis C
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 230 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2004
- Study completion
- May 2005
- 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. Though Alpha-fetoprotein (AFP) and des-γ-carboxy prothrombin(DCP) are used as the tumor markers for diagnosis of HCCs. Thus, 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.
SELDI is a proteomic profiling techniques in biomarker discovery. Its approach has been successfully used to identify biomarkers of various cancers, such as prostate cancer, bladder cancer, ovarian cancer, lung cancer, colon cancer, breast cancer and pancreatic cancer.
In this current project we will apply the SELDI technique to identify the HCC biomarkers. Sera samples from the HCC patients and relevant controls will be collected. We hope that we can find the new HCC biomarkers. If biomarkers of HCC are identified, this can be used to clinical application for the possible early detection of HCCs.
Detailed description
Hepatocellular carcinoma (HCC) has been the leading cause of cancer death in Taiwan. Above 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, AFP is normal in around one third of small(<3cm) HCC patients. Elevated DCP activities were present in 44%-47.6% with HCCs less than 3cm. Thus, 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.
The global analysis of cellular proteins has recently been termed proteomics and is a key area if research that is developing in the postgenomic ear. With respect to cancer, proteomics has the potential to identify novel targets for therapy or markers for diagnosis. The proteomic profiling techniques in biomarker discovery include (1) 2-D PAGE / MALDI-MS (two-dimensional gel electrophoresis, polyacrylamide gel electrophoresis) / matrix assisted laser desorption / ionization-mass spectrometry), (2) LC/MS/MS (liquid chromatography/MS/MS), (3) SELDI-TOF (surface-enhanced laser desorption ionization time-of-flight). These techniques have their own advantages and shortcomings.
SELDI is a recently descried modification of MALDI-TOP in which small amounts of protein are directly applied to a biochip coated with specific chemical matrices (hydrophobic, cationic, anionic, normal phase, and so forth) or biochemical molecules such as DNA oligonucleotides or purified proteins. The bound proteins retained after washing are analyzed by mass spectrometry to obtain the protein fingerprint of the sample. The detected proteins are displayed as a series of peaks.
SELDI-TOF MS can offer high-throughput protein profiles. Blood, urine, body fluid, or tissue specimen are taken from the patients and then are applied onto different ProteinChip Arrays. The differences in the protein expression profiles of two or more distinct samples are thus obtained. SELDI approach has been successfully used to identify biomarkers of various cancers, such as prostate cancer, bladder cancer, ovarian cancer, lung cancer, colon cancer, breast cancer and pancreatic cancer.
In this current project we will apply the SELDI technique to identify the HCC biomarkers. Sera samples from the HCC patients and relevant controls will be collected. The samples will then be applied to SELDI analysis. We hope that we can find the new HCC biomarkers. If biomarkers of HCC are identified, this can be used to clinical application for the possible early detection of HCCs.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of hepatocellular carcinoma
- Clinical diagnosis of hepatitis B
- Clinical diagnosis of hepatitis C
Key exclusion criteria (1 listed)
- N/A
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.
Jin-Chuan Sheu 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 and Hepatitis B, 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 3 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?
Each site lists its own contact: choose the nearest one under Trial locations. 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.