A Retrospective Review of Malignant Liver Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00728650
First received: August 1, 2008
Last updated: February 6, 2012
Last verified: February 2012
  Purpose

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
Liver Cancer

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: A Retrospective Review of Malignant Liver Tumors

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Survival [ Time Frame: lifetime ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy [ Time Frame: lifetime ] [ Designated as safety issue: No ]

Enrollment: 228
Study Start Date: October 2003
Study Completion Date: June 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observation
Patients with primary or metastatic hepatic malignancies

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.

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
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

Criteria

Inclusion Criteria:

  • Patients with primary or metastatic hepatic malignancies

Exclusion Criteria:

  • Patients not diagnosed with primary or metastatic hepatic malignancies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728650

Locations
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
Investigators
Principal Investigator: Thomas A Broughan, MD University of Oklahoma-Tulsa
  More Information

Publications:
Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00728650     History of Changes
Other Study ID Numbers: TAB11119
Study First Received: August 1, 2008
Last Updated: February 6, 2012
Health Authority: United States: Institutional Review Board

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
Neoplasms
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on July 22, 2014