Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Hepatocellular Research Registry

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2010 by Vanderbilt University.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00178893
First received: September 12, 2005
Last updated: August 20, 2010
Last verified: August 2010
  Purpose
This is a registry of human hepatocytes (liver cells) for research purposes.

Condition
Hepatocytes

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: CellzDirect: Hepatocellular Research Registry

Further study details as provided by Vanderbilt University:

Biospecimen Retention:   Samples Without DNA
Hepatocytes

Estimated Enrollment: 200
Study Start Date: April 2004
Estimated Study Completion Date: December 2012
Detailed Description:

Patients scheduled for partial hepatectomy/liver surgery are asked permission to use their discarded liver tissue for purposes of studying:

  1. how drugs/medicines affect the liver and
  2. the effects of storing liver cells in the cold or freezing.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patient having liver resection operation.
Criteria

Inclusion Criteria:

  • Persons undergoing partial hepatectomy/liver surgery for any reason.

Exclusion Criteria:

  • Persons with known HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV)
  • A diagnosis of hepatocellular carcinoma without negative serologies
  • A diagnosis of cholangiocarcinoma, where the total bilirubin has ever been greater or equal to 3.0
  • The presence of a biliary drainage tube
  • Active sepsis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00178893

Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232-4753
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Sunil K Geevarghese, MD, MSCI Vanderbilt University
  More Information

Responsible Party: Sunil K. Geevarghese. MD, MSCI, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00178893     History of Changes
Other Study ID Numbers: 040220 
Study First Received: September 12, 2005
Last Updated: August 20, 2010
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on December 02, 2016