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| 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 |
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
|
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 |
Subject must have hepatocellular carcinoma, or had hepatocellular carcinoma
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Patrice Al-Saden, RN, CCRC | 312-503-1058 | palsaden@northwestern.edu |
| United States, Illinois | |
| Northwestern Memorial Hospital | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Principal Investigator: Laura Kulik, MD | |
| Principal Investigator: | Laura Kulik, MD | Northwestern University, Northwestern Memorial Hospital, Northwestern Medical Faculry Foundation |
More Information
| 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 |
|
Liver Neoplasms Liver Diseases Neoplasms |
Digestive System Diseases Neoplasms by Site Digestive System Neoplasms |