Liver CancerNCT00728650
A Retrospective Review of Malignant Liver Tumors
An observational study of Liver Cancer, run by University of Oklahoma at 1 site in United States.
Trial summary
This study will review the treatment and outcomes of patients having primary and metastatic hepatic malignancies. Patients treated with surgical resection, percutaneous radiofrequency ablation (RFA), and transarterial chemoembolization (TACE) will be compared with patients not receiving these treatments. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Liver Cancer
- How many people
- 228 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Jun 2011
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic and patients treated at St. John Medical Center in Tulsa, OK
Who may be able to join
- Patients with primary or metastatic hepatic malignancies
Who cannot join
- Patients not diagnosed with primary or metastatic hepatic malignancies
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Oklahoma College of Medicine, Tulsa - Department of Surgery
Tulsa, Oklahoma, 74135
About this study
This study will review the treatment and outcomes of patients having primary and metastatic hepatic malignancies. Patients treated with surgical resection, percutaneous radiofrequency ablation (RFA), and transarterial chemoembolization (TACE) will be compared with patients not receiving these treatments. Tumor recurrence and survival data will be compared to the published literature to determine the efficacy of current treatment strategies in this patient population.
Read the detailed description
Subjects will be identified by diagnosis and procedure codes from a university surgical practice and the St. John Medical Center Cancer Registry. Data will be obtained by review of both the clinic and hospital charts. In addition we plan to review and utilize liver tumor treatment and outcomes data from a national database. Treatment decisions, in cases managed by the primary investigator, were made on a clinical basis, often in collaboration with an interventional radiologist. Of the patients managed by the principal investigator, all procedures were undertaken after an informed consent process. Subjects were not exposed to risk beyond that posed by the recommended treatment. All treatments were within the scope of standard medical care. The primary investigator has no knowledge of the treatments chosen for the patients he did not manage. The subject's referring physician may be contacted to obtain follow-up data on the subject. The follow-up data will include: is the patient alive with disease; alive without disease, alive unknown; dead free of disease; dead with disease; dead unknown.
- Conditions
- Liver Cancer
- Keywords
- hepatocellular carcinoma, colorectal carcinoma metastatic to liver, primary liver cancer
- Medical subject headings
- Liver Neoplasms, 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 |
|---|---|---|
| Observation | Patients with primary or metastatic hepatic malignancies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: lifetime
Secondary outcomes (1)
Efficacy
Measured: lifetime
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2008 (estimated)
- Study startOct 2003
- Primary completionOct 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Retrospective
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas A Broughan, MD, Principal investigator, University of Oklahoma-Tulsa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728650
- Sponsor's protocol ID
- TAB11119
- Status last verified
- Feb 2012
- First submitted
- 1 Aug 2008
- Last updated
- 7 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Curley SA, Izzo F, Delrio P, Ellis LM, Granchi J, Vallone P, Fiore F, Pignata S, Daniele B, Cremona F. Radiofrequency ablation of unresectable primary and metastatic hepatic malignancies: results in 123 patients. Ann Surg. 1999 Jul;230(1):1-8. doi: 10.1097/00000658-199907000-00001.
PubMed 10400029
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Review of Malignant Liver Tumors
- ClinicalTrials.gov ID
- NCT00728650
- Acronym / sponsor ID
- TAB11119
- Conditions
- Liver Cancer
- Keywords
- hepatocellular carcinoma, colorectal carcinoma metastatic to liver, primary liver cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- Oct 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 6 Aug 2008 (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 will review the treatment and outcomes of patients having primary and metastatic hepatic malignancies. Patients treated with surgical resection, percutaneous radiofrequency ablation (RFA), and transarterial chemoembolization (TACE) will be compared with patients not receiving these treatments. Tumor recurrence and survival data will be compared to the published literature to determine the efficacy of current treatment strategies in this patient population.
Detailed description
Subjects will be identified by diagnosis and procedure codes from a university surgical practice and the St. John Medical Center Cancer Registry. Data will be obtained by review of both the clinic and hospital charts. In addition we plan to review and utilize liver tumor treatment and outcomes data from a national database. Treatment decisions, in cases managed by the primary investigator, were made on a clinical basis, often in collaboration with an interventional radiologist. Of the patients managed by the principal investigator, all procedures were undertaken after an informed consent process. Subjects were not exposed to risk beyond that posed by the recommended treatment. All treatments were within the scope of standard medical care. The primary investigator has no knowledge of the treatments chosen for the patients he did not manage. The subject's referring physician may be contacted to obtain follow-up data on the subject. The follow-up data will include: is the patient alive with disease; alive without disease, alive unknown; dead free of disease; dead with disease; dead unknown.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | –Patients with primary or metastatic hepatic malignancies |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic and patients treated at St. John Medical Center in Tulsa, OK
Key inclusion criteria (1 listed)
- Patients with primary or metastatic hepatic malignancies
Key exclusion criteria (1 listed)
- Patients not diagnosed with primary or metastatic hepatic malignancies
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
Survival
Time frame: lifetime
1 secondary outcome
Efficacy
Time frame: lifetime
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 7 Feb 2012.
- Results publication: PubMed 10400029Curley SA, Izzo F, Delrio P, Ellis LM, Granchi J, Vallone P, Fiore F, Pignata S, Daniele B, Cremona F. Radiofrequency ablation of unresectable primary and metastatic hepatic malignancies: results in 123 patients. Ann Surg. 1999 Jul;230(1):1-8. doi: 10.1097/00000658-199907000-00001.
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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.
Thomas A Broughan, MD principal investigator
University of Oklahoma-Tulsa
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 University of Oklahoma 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 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: finished, as of the sponsor's last update on 7 Feb 2012. 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?
Survival (time frame: lifetime). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00728650, which also lists 1 linked publication.
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 7 Feb 2012.