Blood Draw Study for Liver Transplant Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT01525797
First received: May 11, 2011
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to see what a lab test will show and if there is a way to predict which patients will be more likely to have rejection after receiving a liver transplant.


Condition
Liver Transplant Recipients

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Immunomonitoring of Transplant Patients

Resource links provided by NLM:


Further study details as provided by Baylor Research Institute:

Primary Outcome Measures:
  • Identify signatures predictive of graft rejection or tolerance. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Analyze the pattern of gene expression in patients undergoing solid organ transplantation


Estimated Enrollment: 200
Study Start Date: October 2002
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control
Rejection

Detailed Description:

The purpose of this study is simply to see what the new oligonucleotide microarrays will show when comparing the the different patient groups. The results of this study will be one of the first steps In exploring the potential use of this new test.

  Eligibility

Ages Eligible for Study:   17 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Liver Clinic

Criteria

Inclusion Criteria:

  • Received a liver Transplant

Exclusion Criteria:

  • Received Multiple Organ Transplant
  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: NCT01525797

Locations
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 752245
Sponsors and Collaborators
Baylor Research Institute
Investigators
Principal Investigator: Goran Klintmalm, MD Baylor Health Care System
  More Information

No publications provided

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT01525797     History of Changes
Other Study ID Numbers: 002-197
Study First Received: May 11, 2011
Last Updated: March 10, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Baylor Research Institute:
Liver Transplant

ClinicalTrials.gov processed this record on August 20, 2014