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

August 1, 2008
February 6, 2012
October 2003
October 2010   (final data collection date for primary outcome measure)
Survival [ Time Frame: lifetime ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00728650 on ClinicalTrials.gov Archive Site
Efficacy [ Time Frame: lifetime ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Retrospective Review of Malignant Liver Tumors
A Retrospective Review of Malignant Liver Tumors

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.

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.

Observational
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

Primary care clinic and patients treated at St. John Medical Center in Tulsa, OK

Liver Cancer
Not Provided
Observation
Patients with primary or metastatic hepatic malignancies
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
228
June 2011
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with primary or metastatic hepatic malignancies

Exclusion Criteria:

  • Patients not diagnosed with primary or metastatic hepatic malignancies
Both
20 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00728650
TAB11119
No
University of Oklahoma
University of Oklahoma
Not Provided
Principal Investigator: Thomas A Broughan, MD University of Oklahoma-Tulsa
University of Oklahoma
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP