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Sponsored by: |
University Health Network, Toronto |
Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00402402 |
The purpose of the study is to estimate the usefulness of the QuantiFERON®-TB Gold test for the diagnosis of latent tuberculosis infection in liver transplant candidates by correlating the test results with risk factors for LTBI
Condition | Intervention | Phase |
Chronic Liver Disease Liver Transplantation Tuberculosis |
Procedure: Tuberculin skin test Procedure: Quantiferon-TB Gold assay |
Phase IV |
MedlinePlus related topics: | Liver Diseases Liver Transplantation Tuberculosis |
ChemIDplus related topics: | Tuberculin Purified Protein Derivative |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | Comparison of Quantiferon-TB Gold Assay With Tuberculin Skin Testing for Detecting Latent Mycobacterium Tuberculosis Infection in Patients With Chronic Liver Disease Awaiting Liver Transplantation |
Estimated Enrollment: | 300 |
Study Start Date: | October 2006 |
Study Completion Date: | July 2007 |
Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Tuberculosis (TB) is an important cause of morbidity and mortality in organ transplant recipients. Although the tuberculin skin test (TST) is recommended for screening of latent tuberculosis infection (LTBI) in all candidates for liver transplantation, the performance of the TST in this setting is less than optimal, due to a lack of specificity and a lack of sensitivity in a population that is relatively immunocompromised. Recently, a new test named QuantiFERON-TB Gold (QFT-G) has been approved for the diagnosis of LTBI. QFT-G is expected to be more specific than TST. However, there are no studies defining the performance of QFT-G in a population of patients on a waiting list for liver transplantation. We plan to estimate the usefulness of the QFT-G test for the diagnosis of LTBI in a cohort of patients with end-stage liver disease. We hypothesize that the QFT-G test will correlate better with the risk of LTBI.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Unable to provide informed consent
Canada, Ontario | |||||
Univcersity Health Network | |||||
Toronto, Ontario, Canada, M5G 2N2 |
University Health Network, Toronto |
Principal Investigator: | Deepali Kumar, MD | University Health Network, Toronto |
Study ID Numbers: | 06-0648-AE |
First Received: | November 21, 2006 |
Last Updated: | April 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00402402 |
Health Authority: | Canada: Health Canada |
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