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临床试验/NCT00866957
NCT00866957已完成不适用

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

Northwestern University1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2006年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
180
试验地点
1
主要终点
HIF-1alpha bio-marker

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Any subject outside of the above inclusion criteria

结局指标

主要结局

HIF-1alpha bio-marker

时间窗: 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.

次要结局

  • Understand biological behavior of the tumors(December 2015)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Laura Kulik

Associate Professor of Medicine, Division of Hepatology

Northwestern University

研究点 (1)

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