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Hepatocellular Research Registry

This study is currently recruiting participants.
Verified February 2017 by Sunil Geevarghese, Vanderbilt University
Sponsor:
ClinicalTrials.gov Identifier:
NCT00178893
First Posted: September 15, 2005
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sunil Geevarghese, Vanderbilt University
  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 Sunil Geevarghese, Vanderbilt University:

Biospecimen Retention:   Samples Without DNA
Hepatocytes

Estimated Enrollment: 200
Actual Study Start Date: April 2004
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): NCT00178893


Contacts
Contact: Carla M Ramsey, RN, BSN 615-936-0834 carla.thomas@Vanderbilt.edu
Contact: Claudia Medlin 615-936-2573 claudia.medlin@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232-4753
Contact: Carla M Ramsey, RN, BSN    615-936-0834    carla.thomas@vanderbilt.edu   
Principal Investigator: Sunil K Geevarghese, MD, MSCI         
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Sunil K Geevarghese, MD, MSCI Vanderbilt University
  More Information

Responsible Party: Sunil Geevarghese, MD, MSCI, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00178893     History of Changes
Other Study ID Numbers: 040220
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: June 14, 2017
Last Verified: February 2017