Human Liver Explants for HIF-1 Alpha Analysis/Comparison (HIF HCC)
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|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
|Condition or disease||Intervention/treatment|
|Liver Cancer||Procedure: Blood draw|
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|
|Actual Enrollment :||180 participants|
|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|
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).
- 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.
- 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
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
|United States, Illinois|
|Northwestern Memorial Hospital|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Laura Kulik, MD||Northwestern University, Northwestern Memorial Hospital, Northwestern Medical Faculty Foundation|