Hepatocellular CarcinomaNCT01482520
Genome-wide Association Study to Predict Treatment Response for Molecular Targeted Therapy in Hepatocellular Carcinoma and Renal Cell Carcinoma
An observational study of Hepatocellular Carcinoma and Renal Cell Carcinoma, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
All Hepatocellular carcinoma and Renal cell carcinoma patients who receive molecular targeted therapy will be candidates for the study. No additional treatment or intervention will be conducted except for blood sampling that will be limited to one time only. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatocellular Carcinoma, Renal Cell Carcinoma
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2008to Oct 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All Hepatocellular carcinoma and Renal cell carcinoma patients who receive molecular targeted therapy will be candidates for the study. Once the patient signed written informed consent, two bottles of 5 cc blood will be drawn and subsequently extracted DNA and serum will be stored until genetic analysis.
Who may be able to join
- All Hepatocellular carcinoma and Renal cell carcinoma patients who receive molecular targeted therapy will be candidates for the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
All Hepatocellular carcinoma and Renal cell carcinoma patients who receive molecular targeted therapy will be candidates for the study.
No additional treatment or intervention will be conducted except for blood sampling that will be limited to one time only.
Blood samples (10 cc in volume) will be collected from all study participants once they provided written informed consent form. DNA will be extracted from peripheral blood samples using DNA isolation kit.
- Conditions
- Hepatocellular Carcinoma, Renal Cell Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular, Carcinoma, Renal Cell
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 |
|---|---|---|
| Renal cell carcinoma | Not described | |
| Hepatocellular carcinoma patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genotypes
To define genotypes of HCC and RCC patients who will likely to response to molecular targeted therapy.
To define genotypes associated with adverse events from molecular targeted.
To identify genotypes which will predict survival or disease-free survival following molecular targeted therapy.
Measured: 36months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startAug 2008
- Primary completionSep 2013
- Study completionOct 2013
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 Samsung Medical CenterThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Yeong Lim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482520
- Sponsor's protocol ID
- 2008-06-050
- Status last verified
- May 2014
- First submitted
- 14 Nov 2011
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genome-wide Association Study to Predict Treatment Response for Molecular Targeted Therapy in Hepatocellular Carcinoma and Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01482520
- Acronym / sponsor ID
- 2008-06-050
- Conditions
- Hepatocellular Carcinoma, Renal Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 30 Nov 2011 (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.
All Hepatocellular carcinoma and Renal cell carcinoma patients who receive molecular targeted therapy will be candidates for the study.
No additional treatment or intervention will be conducted except for blood sampling that will be limited to one time only.
Blood samples (10 cc in volume) will be collected from all study participants once they provided written informed consent form. DNA will be extracted from peripheral blood samples using DNA isolation kit.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal cell carcinoma | – | – |
| Hepatocellular carcinoma patients | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All Hepatocellular carcinoma and Renal cell carcinoma patients who receive molecular targeted therapy will be candidates for the study. Once the patient signed written informed consent, two bottles of 5 cc blood will be drawn and subsequently extracted DNA and serum will be stored until genetic analysis.
Key inclusion criteria (1 listed)
- All Hepatocellular carcinoma and Renal cell carcinoma patients who receive molecular targeted therapy will be candidates for the study
Key exclusion criteria (0 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
Genotypes
Time frame: 36months
To define genotypes of HCC and RCC patients who will likely to response to molecular targeted therapy. To define genotypes associated with adverse events from molecular targeted. To identify genotypes which will predict survival or disease-free survival following molecular targeted therapy.
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 14 May 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Renal Cell Carcinoma, run by Samsung Medical Center at 1 site in South Korea.
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 0 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 14 May 2014. 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 South Korea. 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?
Genotypes (time frame: 36months). 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 14 May 2014.