Hepatocellular CarcinomaNCT00172640
Genetic Studies in Liver Cancer Patients
An observational study of Hepatocellular Carcinoma, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Hepatocellular carcinoma (HCC) is one the most common malignancies in the world, especially in sub-Saharan Africa and Southeast Asia. Since 1984, it has been the leading cause of cancer death in Taiwan. About 6000-8000 people died of this cancer every year in Taiwan. 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
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2005to 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 Differentially Expressed Genes in Hepatocellular Carcinoma With DNA Microarrays
Hepatocellular carcinoma (HCC) is one the most common malignancies in the world, especially in sub-Saharan Africa and Southeast Asia. Since 1984, it has been the leading cause of cancer death in Taiwan. About 6000-8000 people died of this cancer every year in Taiwan. DNA microarray (DNA chip) is a very powerful tool to clarify the genetic changes in cancers. Expression profiling techniques have been used to simultaneously monitor the expression of thousands of genes from human tumor samples. It has been successfully used to predict clinical outcome and survival as well as classify different types of cancer. In this study, we will use the DNA chip to study the genetics in liver cancer patients.
Read the detailed description
The clinical samples will be collected in the NTUH, while the DNA microarray works will be done in Biomedical Engineering Center (BMEC) of ITRI.
Patients A total of 40 cases of HCC patients (20 HBV-related HCC and 20 HCV-related HCC) who received surgical resection in National Taiwan University Hospital will be enrolled from our tissue banks. The diagnosis of HCC was confirmed by pathological examination. The surgical specimens were frozen immediately after surgery and stored in -140°C. The clinicopathological data will be retrospectively obtained from chart reviews.
Another total of 40 new HCC patients who receive surgical resection in National Taiwan University Hospital will be collected. The healthy subjects and patients chronically infected with HBV or HCV without HCC will be used as controls. The whole bloods will be collected before, one and six months after operation. The diagnosis of HCC will be confirmed by pathology. In addition to the whole bloods, the surgical specimens will be frozen immediately after surgery and stored in -140°C.
- 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 posted15 Sep 2005 (estimated)
- Study startJan 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
- Defined population
- Time perspective
- Other
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Industrial Technology Research Institute, Taiwan
- Investigators
- Chien-Hung Chen, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00172640
- Sponsor's protocol ID
- 9361701211
- Status last verified
- Dec 2004
- First submitted
- 12 Sep 2005
- Last updated
- 15 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Differentially Expressed Genes in Hepatocellular Carcinoma With DNA Microarrays
- ClinicalTrials.gov ID
- NCT00172640
- Acronym / sponsor ID
- 9361701211
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Industrial Technology Research Institute, Taiwan
- Study start
- Jan 2005
- First posted
- 15 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) is one the most common malignancies in the world, especially in sub-Saharan Africa and Southeast Asia. Since 1984, it has been the leading cause of cancer death in Taiwan. About 6000-8000 people died of this cancer every year in Taiwan. DNA microarray (DNA chip) is a very powerful tool to clarify the genetic changes in cancers. Expression profiling techniques have been used to simultaneously monitor the expression of thousands of genes from human tumor samples. It has been successfully used to predict clinical outcome and survival as well as classify different types of cancer. In this study, we will use the DNA chip to study the genetics in liver cancer patients.
Detailed description
The clinical samples will be collected in the NTUH, while the DNA microarray works will be done in Biomedical Engineering Center (BMEC) of ITRI.
Patients A total of 40 cases of HCC patients (20 HBV-related HCC and 20 HCV-related HCC) who received surgical resection in National Taiwan University Hospital will be enrolled from our tissue banks. The diagnosis of HCC was confirmed by pathological examination. The surgical specimens were frozen immediately after surgery and stored in -140°C. The clinicopathological data will be retrospectively obtained from chart reviews.
Another total of 40 new HCC patients who receive surgical resection in National Taiwan University Hospital will be collected. The healthy subjects and patients chronically infected with HBV or HCV without HCC will be used as controls. The whole bloods will be collected before, one and six months after operation. The diagnosis of HCC will be confirmed by pathology. In addition to the whole bloods, the surgical specimens will be frozen immediately after surgery and stored in -140°C.
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 15 Sep 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 15 Sep 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 15 Sep 2005.