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A Retrospective Review of Malignant Liver Tumors

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ClinicalTrials.gov Identifier: NCT00728650
Recruitment Status : Completed
First Posted : August 6, 2008
Last Update Posted : February 7, 2012
Information provided by (Responsible Party):
University of Oklahoma

Brief 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. Tumor recurrence and survival data will be compared to the published literature to determine the efficacy of current treatment strategies in this patient population.

Condition or disease
Liver Cancer

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 Type : Observational
Actual Enrollment : 228 participants
Time Perspective: Retrospective
Official Title: A Retrospective Review of Malignant Liver Tumors
Study Start Date : October 2003
Primary Completion Date : October 2010
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer
U.S. FDA Resources

Patients with primary or metastatic hepatic malignancies

Primary Outcome Measures :
  1. Survival [ Time Frame: lifetime ]

Secondary Outcome Measures :
  1. Efficacy [ Time Frame: lifetime ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic and patients treated at St. John Medical Center in Tulsa, OK

Inclusion Criteria:

  • Patients with primary or metastatic hepatic malignancies

Exclusion Criteria:

  • Patients not diagnosed with primary or metastatic hepatic malignancies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00728650

United States, Oklahoma
The University of Oklahoma College of Medicine, Tulsa - Department of Surgery
Tulsa, Oklahoma, United States, 74135
Sponsors and Collaborators
University of Oklahoma
Principal Investigator: Thomas A Broughan, MD University of Oklahoma-Tulsa

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00728650     History of Changes
Other Study ID Numbers: TAB11119
First Posted: August 6, 2008    Key Record Dates
Last Update Posted: February 7, 2012
Last Verified: February 2012

Keywords provided by University of Oklahoma:
hepatocellular carcinoma
colorectal carcinoma metastatic to liver
primary liver cancer

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases