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

Sponsor:	Northwestern University
Collaborator:	Feinberg School of Medicine, Northwestern University
Information provided by (Responsible Party):	Laura Kulik, Northwestern University
ClinicalTrials.gov Identifier:	NCT00866957

Purpose

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.

Condition	Intervention
Liver Cancer	Procedure: Blood draw

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Human Liver Explants for HIF-1 Alpha- Analysis/Comparison

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer

U.S. FDA Resources

Further study details as provided by Northwestern University:

Biospecimen Retention: Samples With DNA

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

Estimated Enrollment:	500
Study Start Date:	February 2006
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Patients with liver cancer Patients diagnosed with 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).

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Subject must have hepatocellular carcinoma, or had hepatocellular carcinoma

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00866957

Contacts

Contact: Patrice Al-Saden, RN, CCRC

312-694-0232

palsaden@northwestern.edu

Locations

United States, Illinois
Northwestern Memorial Hospital	Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Laura Kulik, MD

Sponsors and Collaborators

Northwestern University

Feinberg School of Medicine, Northwestern University

Investigators

Principal Investigator:

Laura Kulik, MD

Northwestern University, Northwestern Memorial Hospital, Northwestern Medical Faculty Foundation

More Information

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Responsible Party:	Laura Kulik, Assistant Professor of Medicine, Division of Hepatology, Northwestern University
ClinicalTrials.gov Identifier:	NCT00866957 History of Changes
Other Study ID Numbers:	STU8344 1530-004
Study First Received:	March 19, 2009
Last Updated:	August 25, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site

Neoplasms
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on February 09, 2012