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Comparison of Quantiferon-TB Gold Assay With Tuberculin Skin Testing in Patients With Chronic Liver Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00402402
Recruitment Status : Completed
First Posted : November 22, 2006
Last Update Posted : April 16, 2008
Information provided by:
University Health Network, Toronto

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Liver Disease Liver Transplantation Tuberculosis Procedure: Tuberculin skin test Procedure: Quantiferon-TB Gold assay Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Start Date : October 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Concordance between the Quantiferon-TB Gold assay and the tuberculin skin test
  2. Correlation of the test results to the patient's risk of latent TB infection

Secondary Outcome Measures :
  1. Factors associated with discordance between the TST and the QFT-G test
  2. Frequency of anergy in this patient population

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Chronic liver disease on the waiting list or being wait listed for liver transplantation

Exclusion Criteria:

  • Unable to provide informed consent

    • Previous history of immediate hypersensitivity to TST
    • Previous severe local ulceration with TST
    • Suspected active TB

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 identifier (NCT number): NCT00402402

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Canada, Ontario
Univcersity Health Network
Toronto, Ontario, Canada, M5G 2N2
Sponsors and Collaborators
University Health Network, Toronto
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Principal Investigator: Deepali Kumar, MD University Health Network, Toronto
Layout table for additonal information Identifier: NCT00402402    
Other Study ID Numbers: 06-0648-AE
First Posted: November 22, 2006    Key Record Dates
Last Update Posted: April 16, 2008
Last Verified: November 2006
Keywords provided by University Health Network, Toronto:
Tuberculin skin test
Quantiferon-TB Gold assay
Chronic liver disease
Liver transplantation
Latent tuberculosis infection
Additional relevant MeSH terms:
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Liver Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Digestive System Diseases