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Hepatocellular Research Registry

This study is currently recruiting participants.
See Contacts and Locations
Verified February 2017 by Sunil Geevarghese, Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Sunil Geevarghese, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00178893
First received: September 12, 2005
Last updated: June 10, 2017
Last verified: February 2017
  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

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
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

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
Study First Received: September 12, 2005
Last Updated: June 10, 2017

ClinicalTrials.gov processed this record on June 22, 2017