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: 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.
Observational
Observational Model: Cohort, Time Perspective: Prospective
HIF-1alpha bio-marker
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.
Decemebr 2015
No
Laura Kulik, MD
Principal Investigator
Northwestern University, Northwestern Memorial Hospital, Northwestern Medical Faculty Foundation
United States: Institutional Review Board
STU8344 1530-004
NCT00866957
February 2006
December 2015
Name | Location |
---|---|
Northwestern Memorial Hospital | Chicago, Illinois 60611 |