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A2ALL Human Liver Explants for HIF-1 Alpha Analysis/Comparison (HIF HCC)
This study is currently recruiting participants.
Verified by Northwestern University, October 2009
First Received: March 19, 2009   Last Updated: October 16, 2009   History of Changes
Sponsor: Northwestern University
Collaborator: Northwester Memorial Hospital Division of Organ Transplantation
Information provided by: 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
Liver Cancer

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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

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


Estimated Enrollment: 500
Study Start Date: February 2006
Groups/Cohorts
1
Patients diagnosed with liver cancer

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 312-503-1058 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
Northwester Memorial Hospital Division of Organ Transplantation
Investigators
Principal Investigator: Laura Kulik, MD Northwestern University, Northwestern Memorial Hospital, Northwestern Medical Faculry Foundation
  More Information

No publications provided

Responsible Party: Northwestern University ( Laura Kulik, MD )
Study ID Numbers: STU83441530-004
Study First Received: March 19, 2009
Last Updated: October 16, 2009
ClinicalTrials.gov Identifier: NCT00866957     History of Changes
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Liver Neoplasms
Liver Diseases
Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010