Hepatocellular CarcinomaNCT01247506
Different Genetic Features Associated With Hepatic Carcinogenesis
An observational study of Hepatocellular Carcinoma, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to identify different genetic features in hepatocellular carcinoma. It will assist in predicting individual risks of disease progression and would help to clarify pathophysiological mechanisms of HCC. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 160 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2010to Jul 2012
- 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 160 patients with histologically proven HCC were collected by Dr. Po-Huang Lee's Lab (The Department of Surgery, National Taiwan University Hospital, Taipei, Taiwan)
Who may be able to join
- clinical diagnosis of hepatocellular carcinoma
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Cheng-Maw HO
About this study
Official title: Identification of Survival-related microRNAs in Hepatocellular Carcinoma
The purpose of this study is to identify different genetic features in hepatocellular carcinoma. It will assist in predicting individual risks of disease progression and would help to clarify pathophysiological mechanisms of HCC.
Read the detailed description
Hepatocellular carcinoma (HCC) is a leading cause of cancer deaths in Taiwan. HCC normally develops as a consequence of underlying liver disease and is most often associated with cirrhosis. Surgical resection and liver transplantation are current best curative options to treat HCC. However, recurrence or metastasis is quite common in patients who have had a resection and survival rate is 30% to 40% at 5 years postoperatively.
MicroRNAs, small non-coding RNA, act as endogenous RNA interference by post-transcription regulation. Recent studies suggest that microRNAs may act as tumor suppressors or oncogenes and altered microRNA expression levels may play an important role in the cancer initiation and progression. Several studies, including ourselves, have shown that specific microRNAs are aberrantly expressed in malignant HCC tissues compared to normal counterpart. Although many microRNA profiling studies were done to diagnose hepatocarcinogenesis, data about prognostic significances for postsurgical survival are very limited. The main point of this study is to develop a predictive signature for postsurgical survival in HCC patients.
- Conditions
- Hepatocellular Carcinoma
- Keywords
- microRNA
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | tumor tissues of HCC patients | |
| 2 | paired nontumor tissues of HCC patients |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
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
- Retrospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Investigators
- Po-Huang Lee, PhD, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247506
- Sponsor's protocol ID
- 200912020R
- Status last verified
- Nov 2010
- First submitted
- 22 Nov 2010
- Last updated
- 24 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Survival-related microRNAs in Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01247506
- Acronym / sponsor ID
- 200912020R
- Conditions
- Hepatocellular Carcinoma
- Keywords
- microRNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Feb 2010
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 24 Nov 2010 (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.
The purpose of this study is to identify different genetic features in hepatocellular carcinoma. It will assist in predicting individual risks of disease progression and would help to clarify pathophysiological mechanisms of HCC.
Detailed description
Hepatocellular carcinoma (HCC) is a leading cause of cancer deaths in Taiwan. HCC normally develops as a consequence of underlying liver disease and is most often associated with cirrhosis. Surgical resection and liver transplantation are current best curative options to treat HCC. However, recurrence or metastasis is quite common in patients who have had a resection and survival rate is 30% to 40% at 5 years postoperatively.
MicroRNAs, small non-coding RNA, act as endogenous RNA interference by post-transcription regulation. Recent studies suggest that microRNAs may act as tumor suppressors or oncogenes and altered microRNA expression levels may play an important role in the cancer initiation and progression. Several studies, including ourselves, have shown that specific microRNAs are aberrantly expressed in malignant HCC tissues compared to normal counterpart. Although many microRNA profiling studies were done to diagnose hepatocarcinogenesis, data about prognostic significances for postsurgical survival are very limited. The main point of this study is to develop a predictive signature for postsurgical survival in HCC patients.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –tumor tissues of HCC patients |
| 2 | – | –paired nontumor tissues of HCC patients |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 160 patients with histologically proven HCC were collected by Dr. Po-Huang Lee's Lab (The Department of Surgery, National Taiwan University Hospital, Taipei, Taiwan)
Key inclusion criteria (1 listed)
- clinical diagnosis of hepatocellular carcinoma
Key exclusion criteria (1 listed)
- -
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 24 Nov 2010.
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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.
Po-Huang Lee, PhD study chair
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 24 Nov 2010. 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 Tzu-Min Hung, PhD (886-2-23123456 ext. 65956, mean6722@ms65.hinet.net), 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 24 Nov 2010.