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Human Liver Explants for HIF-1 Alpha- Analysis/Comparison

18 Years
Open (Enrolling)
Liver Cancer

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Trial Information

Human Liver Explants for HIF-1 Alpha- Analysis/Comparison

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:, 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.

Inclusion Criteria:

- Adults, any gender ≥ to 18 years of age

- Previous, or current diagnosis of hepatocellular carcinoma (clinical or biopsy

- 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 NMH.

- Patients previously diagnosed or, recently diagnosed with liver cancer that were
treated, currently are being treated our will potentially undergo treatment for the

Exclusion Criteria:

- Any subject outside of the above inclusion criteria

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

HIF-1alpha bio-marker

Outcome Description:

The primary objective is to compare levels of HIF-1alpha expression in HCC tumor explants which have received: 1) no pre-explant embolization; 2) pre-explant TACE; 3) pre-explant Y90 radioembolization; 4) pre-explant radiofrequnecy ablation, or 5) a combination of pre-explant therapies.

Outcome Time Frame:

Decemebr 2015

Safety Issue:


Principal Investigator

Laura Kulik, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University, Northwestern Memorial Hospital, Northwestern Medical Faculty Foundation


United States: Institutional Review Board

Study ID:

STU8344 1530-004



Start Date:

February 2006

Completion Date:

December 2015

Related Keywords:

  • Liver Cancer
  • Liver Neoplasms



Northwestern Memorial HospitalChicago, Illinois  60611