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

NCT00866957 | Completed

• 1 other identifier: STU8344 1530-004
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (1)

• HIF-1alpha bio-marker

  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 Outcomes (1)

• Understand biological behavior of the tumors

  December 2015

Study Arms (1)

Patients with liver cancer

Patients diagnosed with liver cancer

Procedure: Blood draw

Interventions

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).

Patients with liver cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subject must have hepatocellular carcinoma, or had hepatocellular carcinoma

You may qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• Northwestern University Feinberg School of Medicine: collaborator

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

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Biospecimen

Retention: SAMPLES WITH DNA

Both, samples with DNA and without: serum, plasma, genomic samples, \& liver biopsy specimens

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Laura Kulik, MD

  Northwestern University, Northwestern Memorial Hospital, Northwestern Medical Faculty Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, Division of Hepatology

Study Record Dates

• First Submitted: March 19, 2009
• First Posted: March 23, 2009
• Study Start: February 1, 2006
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

US (1)