A2ALL Human Liver Explants for HIF-1 Alpha Analysis/Comparison (HIF HCC)

This study is currently recruiting participants.
Verified September 2012 by Northwestern University
Sponsor:
Collaborator:
Feinberg School of Medicine, Northwestern University
Information provided by (Responsible Party):
Laura Kulik, Northwestern University
ClinicalTrials.gov Identifier:
NCT00866957
First received: March 19, 2009
Last updated: September 26, 2012
Last verified: September 2012

March 19, 2009
September 26, 2012
February 2006
December 2013   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00866957 on ClinicalTrials.gov Archive Site
 
 
 
 
 
A2ALL Human Liver Explants for HIF-1 Alpha Analysis/Comparison (HIF HCC)
Human Liver Explants for HIF-1 Alpha- Analysis/Comparison

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.

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
Retention:   Samples With DNA
Description:

Both, samples with DNA and without: serum, plasma, genomic samples, & liver biopsy specimens

Non-Probability Sample

Subject must have hepatocellular carcinoma, or had hepatocellular carcinoma

Liver Cancer
Procedure: Blood draw
A two-time blood draw: one prior to cancer treatment, the second after cancer treatment. Total amount of blood approximately 8 teaspoons (40mL).
Patients with liver cancer
Patients diagnosed with liver cancer
Intervention: Procedure: Blood draw

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
December 2015
December 2013   (final data collection date for primary outcome measure)

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 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
Both
18 Years and older
No
Contact: Patrice Al-Saden, RN, CCRC 312-694-0232 palsaden@northwestern.edu
United States
 
NCT00866957
STU8344 1530-004
No
Laura Kulik, Northwestern University
Northwestern University
Feinberg School of Medicine, Northwestern University
Principal Investigator: Laura Kulik, MD Northwestern University, Northwestern Memorial Hospital, Northwestern Medical Faculty Foundation
Northwestern University
September 2012

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