Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00866957
Recruitment Status : Unknown
Verified April 2019 by Laura Kulik, Northwestern University.
Recruitment status was:  Active, not recruiting
First Posted : March 23, 2009
Last Update Posted : June 5, 2019
Sponsor:
Collaborator:
Feinberg School of Medicine, Northwestern University
Information provided by (Responsible Party):
Laura Kulik, Northwestern University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment
Liver Cancer Procedure: Blood draw

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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Human Liver Explants for HIF-1 Alpha- Analysis/Comparison
Study Start Date : February 2006
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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).


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. HIF-1alpha bio-marker [ Time Frame: December 2015 ]
    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 Transcatheter arterial chemoembolization (TACE); 3) pre-explant Y90 radio-embolization; 4) pre-explant radiofrequency ablation, or 5) a combination of pre-explant therapies.


Secondary Outcome Measures :
  1. Understand biological behavior of the tumors [ Time Frame: December 2015 ]
    Collect blood specimens on those subjects that have had hepatocellular carcinoma, or those currently being treated for it with any of the above mentioned treatments to screen for biomarkers.


Biospecimen Retention:   Samples With DNA
Both, samples with DNA and without: serum, plasma, genomic samples, & liver biopsy specimens

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 Northwestern Memorial Hospital (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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00866957


Locations
Layout table for location information
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Feinberg School of Medicine, Northwestern University
Investigators
Layout table for investigator information
Principal Investigator: Laura Kulik, MD Northwestern University, Northwestern Memorial Hospital, Northwestern Medical Faculty Foundation
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Laura Kulik, Associate Professor of Medicine, Division of Hepatology, Northwestern University
ClinicalTrials.gov Identifier: NCT00866957    
Other Study ID Numbers: STU8344 1530-004
First Posted: March 23, 2009    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Liver Diseases