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A Retrospective Review of Malignant Liver Tumors

This study is ongoing, but not recruiting participants.

Sponsored by: University of Oklahoma
Information provided by: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00728650
  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

MedlinePlus related topics:   Cancer    Liver Cancer   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Other, Retrospective
Official Title:   A Retrospective Review of Malignant Liver Tumors

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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   500
Study Start Date:   October 2003
Estimated Study Completion Date:   October 2010
Estimated 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

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 of Results:

Responsible Party:   The University of Oklahoma College of Medicine, Tulsa ( Thomas A. Broughan, MD Professor and Chair )
Study ID Numbers:   TAB11119
First Received:   August 1, 2008
Last Updated:   August 1, 2008
ClinicalTrials.gov Identifier:   NCT00728650
Health Authority:   United States: Institutional Review Board

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

Study placed in the following topic categories:
Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms
Gastrointestinal Neoplasms
Hepatocellular carcinoma
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on September 22, 2008




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