Clinical trial NCT00866957: Human Liver Explants for HIF-1 Alpha Analysis/Comparison (HIF HCC)
Official title: Human Liver Explants for HIF-1 Alpha- Analysis/Comparison
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cancer
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Northwestern University Feinberg School of Medicine
First posted: 2009-03-23
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject must have hepatocellular carcinoma, or had hepatocellular carcinoma

Brief summary: The purpose of the study is to compare levels of HIF-1 α (Hypoxia Inducing Factor 1-alpha) in patients who have been treated with various types of liver cancer treatments.

Detailed description: In the currently ongoing retrospective aspect of the study, we will obtain pathologic tumor explant specimens from the tumor explant population from 8/1/1994 to 12/31/2005. We will prepare 5-10 slides from each tumor explant block and measure HIF-1α using immunohistochemical staining. We will also be performing a retrospective chart review for specific data points which we believe are needed to assist us in our analysis of the histopathologic specimens.

In addition, we will be looking at data in the United Network for Organ Sharing (UNOS) database: www.unos.org, which will allow us to develop a more thorough and robust analysis of the subject's experience with liver cancer. This is a public, mandatory reporting vehicle that the government mandates all transplant centers to report to. Even if the subject was transplanted at Northwestern, and moved, accessing UNOS data will allow us to see what the morbidity/mortality for that patient is.

Secondly, we will start enrolling subjects in a prospective fashion. Those that either have been treated, those currently undergoing treatment, or those newly diagnosed. From these subjects we will obtain informed consent to; a) look at the medical records (current, future and retrospective data), b) collect blood specimens for future analysis and correlation with their explant slide data, c) allow us to follow these subjects indefinitely to obtain ongoing outcomes data, morbidity and mortality information.

Eligibility criteria: Inclusion Criteria:

* Adults, any gender ≥ to 18 years of age
* Previous, or current diagnosis of hepatocellular carcinoma (clinical or biopsy proven)
* Resection for hepatoma and/or transplant
* Patients with diagnosis of hepatocellular carcinoma from 8/1/94 thru 12/31/05 (retrospective) with biopsy, explant and/or liver transplantation here at Northwestern Memorial Hospital (NMH).
* Patients previously diagnosed or, recently diagnosed with liver cancer that were treated, currently are being treated our will potentially undergo treatment for the disease.

Exclusion Criteria:

* Any subject outside of the above inclusion criteria

Primary outcomes:
measure: HIF-1alpha bio-marker
timeFrame: December 2015
Secondary outcomes:
measure: Understand biological behavior of the tumors
timeFrame: December 2015
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University, Northwestern Memorial Hospital, Northwestern Medical Faculty Foundation
name: Laura Kulik, MD
role: PRINCIPAL_INVESTIGATOR
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