Liver CancerNCT01539993
Prospective Liver Study
An observational study of Liver Cancer, run by Emory University at 1 site in United States.
Trial summary
This study is designed for patients diagnosed with Liver cancer to collect information about the relationship between types of liver cancer, methods of treatment and outcomes over time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Jan 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 18 yrs and older with a diagnosis of Hepatocellular carcinoma and elegible for percutaneous liver treatments
Who may be able to join
- Patients diagnosed with Hepatocellular carcinoma and referred for percutaneous liver treatment.
Who cannot join
- Severe liver disfunction
- Active uncontrolled infection
- Significant underlying medical of physical illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Analysis of Liver Cancer Treatment and Interventions
This study is designed for patients diagnosed with Liver cancer to collect information about the relationship between types of liver cancer, methods of treatment and outcomes over time.
- Conditions
- Liver Cancer
- Keywords
- Hepatocellular carcinoma, Liver metastases, Cholangiocarcinoma, Percutaneous treatments, RFA, TACE, DEB
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular, Cholangiocarcinoma
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 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess efficacy of percutaneous and transarterial treatments for liver cancer.
QOL questionnaire will be collected during follow up visit.
Measured: 1 month
Secondary outcomes (1)
long term follow up
Patients will be administered QOL during 3 months, 6 months and 1 year follow up.
Measured: 3 months, 6 months 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2012 (estimated)
- Study startNov 2008
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun Kevin Kim, Emory University
- Investigators
- Kevin S Kim, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539993
- Sponsor's protocol ID
- IRB00014768
- Status last verified
- May 2014
- First submitted
- 15 Feb 2012
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of Liver Cancer Treatment and Interventions
- ClinicalTrials.gov ID
- NCT01539993
- Acronym / sponsor ID
- IRB00014768
- Conditions
- Liver Cancer
- Keywords
- Hepatocellular carcinoma, Liver metastases, Cholangiocarcinoma, Percutaneous treatments, RFA, TACE, DEB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 28 Feb 2012 (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.
This study is designed for patients diagnosed with Liver cancer to collect information about the relationship between types of liver cancer, methods of treatment and outcomes over time.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 yrs and older with a diagnosis of Hepatocellular carcinoma and elegible for percutaneous liver treatments
Key inclusion criteria (1 listed)
- Patients diagnosed with Hepatocellular carcinoma and referred for percutaneous liver treatment.
Key exclusion criteria (3 listed)
- Severe liver disfunction
- Active uncontrolled infection
- Significant underlying medical of physical illness
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
Assess efficacy of percutaneous and transarterial treatments for liver cancer.
Time frame: 1 month
QOL questionnaire will be collected during follow up visit.
1 secondary outcome
long term follow up
Time frame: 3 months, 6 months 1year
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 28 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.
Kevin S Kim, MD principal investigator
Emory University
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 Liver Cancer, run by Emory University at 1 site in United States.
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 3 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 28 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 United States. 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?
Assess efficacy of percutaneous and transarterial treatments for liver cancer. (time frame: 1 month). 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 28 May 2014.