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

This study has been completed.
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00402402
First received: November 21, 2006
Last updated: April 15, 2008
Last verified: November 2006
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

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

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

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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00402402

Locations
Canada, Ontario
Univcersity Health Network
Toronto, Ontario, Canada, M5G 2N2
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Deepali Kumar, MD University Health Network, Toronto
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00402402     History of Changes
Other Study ID Numbers: 06-0648-AE
Study First Received: November 21, 2006
Last Updated: April 15, 2008
Health Authority: Canada: Health Canada

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:
Liver Diseases
Tuberculosis
Digestive System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 23, 2014