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

November 16, 2023 updated by: Laura Kulik, Northwestern University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subject must have hepatocellular carcinoma, or had hepatocellular carcinoma

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
December 2015

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
December 2015

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Northwestern University Feinberg School of Medicine

Investigators

  • Principal Investigator: Laura Kulik, MD, Northwestern University, Northwestern Memorial Hospital, Northwestern Medical Faculty Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

March 19, 2009

First Submitted That Met QC Criteria

March 19, 2009

First Posted (Estimated)

March 23, 2009

Study Record Updates

Last Update Posted (Actual)

November 18, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU8344 1530-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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