Expired Study
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Tulsa, Oklahoma 74135


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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Patients with primary or metastatic hepatic malignancies Exclusion Criteria: - Patients not diagnosed with primary or metastatic hepatic malignancies


Study is Available At:


Original ID:

TAB11119


NCT ID:

NCT00728650


Secondary ID:


Study Acronym:


Brief Title:

A Retrospective Review of Malignant Liver Tumors


Official Title:

A Retrospective Review of Malignant Liver Tumors


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

20 Years


Maximum Age:

90 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Oklahoma


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Time Perspective: Retrospective


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

228


Enrollment Type:

Actual


Overall Contact Information

Official Name:Thomas A Broughan, MD
Principal Investigator
University of Oklahoma-Tulsa

Study Dates

Start Date:October 2003
Completion Date:June 2011
Completion Type:Actual
Primary Completion Date:October 2010
Primary Completion Type:Actual
Verification Date:February 2012
Last Changed Date:February 6, 2012
First Received Date:August 1, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Survival
Time Frame:lifetime
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Efficacy
Time Frame:lifetime
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Observation
Description:Patients with primary or metastatic hepatic malignancies

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Oklahoma

Samples and Retentions

Study Population: Primary care clinic and patients treated at St. John Medical Center in Tulsa, OK
Sample Method:Non-Probability Sample

Study References

Reference Type:Results Reference
Citation: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.
PMID:10400029

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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