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

Phase 4

Completed

• Conditions: Chronic Liver Disease; Liver Transplantation; Tuberculosis

• Registration Number: NCT00402402
• Lead Sponsor: 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

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.

Study Timeline

• Study Start: 2006-10
• Status Verified: 2006-11
• Study First Submitted: 2006-11-21
• Study First Submitted QC: 2006-11-21
• Study First Posted: 2006-11-22
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Last Update Submitted: 2008-04-15
• Last Update Posted: 2008-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

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Exclusion Criteria

• Unable to provide informed consent

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Factors associated with discordance between the TST and the QFT-G test
Frequency of anergy in this patient population

Trial Locations

Locations (1)

Univcersity Health Network; 🇨🇦 Toronto, Ontario, Canada