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Hepatocellular Research Registry

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ClinicalTrials.gov Identifier: NCT00178893
Recruitment Status : Recruiting
First Posted : September 15, 2005
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Sunil Geevarghese, Vanderbilt University

Brief Summary:
This is a registry of human hepatocytes (liver cells) for research purposes.

Condition or disease
Hepatocytes

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.

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: CellzDirect: Hepatocellular Research Registry
Actual Study Start Date : April 2004
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2022



Biospecimen Retention:   Samples Without DNA
Hepatocytes


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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

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

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