Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00402402
Status:
COMPLETED
Last Update Posted:
2008-04-16
First Post:
2006-11-21
Brief Title:
Comparison of Quantiferon-TB Gold Assay With Tuberculin Skin Testing in Patients With Chronic Liver Disease
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2006-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None