- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01525797
Blood Draw Study for Liver Transplant Patients
March 13, 2015 updated by: Baylor Research Institute
Immunomonitoring of Transplant Patients
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.
Study Overview
Status
Unknown
Conditions
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.
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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Dallas, Texas, United States, 752245
- Baylor University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Liver Clinic
Description
Inclusion Criteria:
- Received a liver Transplant
Exclusion Criteria:
- Received Multiple Organ Transplant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Control
|
Rejection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identify signatures predictive of graft rejection or tolerance.
Time Frame: 2 years
|
Analyze the pattern of gene expression in patients undergoing solid organ transplantation
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Goran Klintmalm, MD, Baylor Health Care System
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2002
Primary Completion (Anticipated)
November 1, 2015
Study Completion (Anticipated)
November 1, 2015
Study Registration Dates
First Submitted
May 11, 2011
First Submitted That Met QC Criteria
February 1, 2012
First Posted (Estimate)
February 3, 2012
Study Record Updates
Last Update Posted (Estimate)
March 17, 2015
Last Update Submitted That Met QC Criteria
March 13, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 002-197
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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