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Completed

NCT Number: NCT00866957

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood draw

Procedure

A two-time blood draw: one prior to cancer treatment, the second after cancer treatment. Total amount of blood approximately 8 teaspoons (40mL).

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Human Liver Explants for HIF-1 Alpha- Analysis/Comparison

Important dates

Study start
2006
Primary completion
2019
Study completion
2019
First posted
Mar 23, 2009
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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