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

Primary Purpose

Chronic Liver Disease, Liver Transplantation, Tuberculosis

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Tuberculin skin test
Quantiferon-TB Gold assay
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Liver Disease focused on measuring Tuberculin skin test, Quantiferon-TB Gold assay, Chronic liver disease, Liver transplantation, Latent tuberculosis infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Univcersity Health Network

Outcomes

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

Full Information

First Posted
November 21, 2006
Last Updated
April 15, 2008
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT00402402
Brief Title
Comparison of Quantiferon-TB Gold Assay With Tuberculin Skin Testing in Patients With Chronic Liver Disease
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 Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Health Network, Toronto

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Liver Disease, Liver Transplantation, Tuberculosis
Keywords
Tuberculin skin test, Quantiferon-TB Gold assay, Chronic liver disease, Liver transplantation, Latent tuberculosis infection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Tuberculin skin test
Intervention Type
Procedure
Intervention Name(s)
Quantiferon-TB Gold assay
Primary Outcome Measure Information:
Title
Concordance between the Quantiferon-TB Gold assay and the tuberculin skin test
Title
Correlation of the test results to the patient's risk of latent TB infection
Secondary Outcome Measure Information:
Title
Factors associated with discordance between the TST and the QFT-G test
Title
Frequency of anergy in this patient population

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepali Kumar, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univcersity Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
12451235
Citation
Benito N, Sued O, Moreno A, Horcajada JP, Gonzalez J, Navasa M, Rimola A. Diagnosis and treatment of latent tuberculosis infection in liver transplant recipients in an endemic area. Transplantation. 2002 Nov 27;74(10):1381-6. doi: 10.1097/00007890-200211270-00006.
Results Reference
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PubMed Identifier
15961696
Citation
Ferrara G, Losi M, Meacci M, Meccugni B, Piro R, Roversi P, Bergamini BM, D'Amico R, Marchegiano P, Rumpianesi F, Fabbri LM, Richeldi L. Routine hospital use of a new commercial whole blood interferon-gamma assay for the diagnosis of tuberculosis infection. Am J Respir Crit Care Med. 2005 Sep 1;172(5):631-5. doi: 10.1164/rccm.200502-196OC. Epub 2005 Jun 16.
Results Reference
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PubMed Identifier
15941804
Citation
Pai M, Gokhale K, Joshi R, Dogra S, Kalantri S, Mendiratta DK, Narang P, Daley CL, Granich RM, Mazurek GH, Reingold AL, Riley LW, Colford JM Jr. Mycobacterium tuberculosis infection in health care workers in rural India: comparison of a whole-blood interferon gamma assay with tuberculin skin testing. JAMA. 2005 Jun 8;293(22):2746-55. doi: 10.1001/jama.293.22.2746.
Results Reference
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Comparison of Quantiferon-TB Gold Assay With Tuberculin Skin Testing in Patients With Chronic Liver Disease

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