Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134342
Status:
COMPLETED
Last Update Posted:
2010-12-23
First Post:
2005-08-22
Brief Title:
Tuberculosis TB Screening for the Diagnosis of Latent TB in Immunocompromised Populations
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Comparison of Traditional Tuberculosis Screening Methods With the T-SPOT TB Test for the Diagnosis of Latent Tuberculosis Infection in Immunocompromised Populations
Status:
COMPLETED
Status Verified Date:
2005-07
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 tuberculin skin test TST has been the gold standard for diagnosing latent tuberculosis for almost 100 years While this test performs reasonably well in healthy non-bacille Calmette-Guerin BCG vaccinated populations it is believed to perform less well in patients who do not have intact cellular immune systems immunocompromised
The investigators hypothesize that a new test the T-SPOT TB ELISPOT test will provide a more accurate measurement of latent infection in immunocompromised people This study will compare the TST to the T-SPOT TB ELISPOT test and to the results of an expert physician diagnostic panel
The investigators hypothesize that a new test the T-SPOT TB ELISPOT test will provide a more accurate measurement of latent infection in immunocompromised people This study will compare the TST to the T-SPOT TB ELISPOT test and to the results of an expert physician diagnostic panel
Detailed Description:
Main Study Question
We propose to investigate the correlation between the traditional TST-based method of screening for latent tuberculosis infection in specific immunocompromised populations as recommended by Canadian and American standards the T-SPOT TB ELISPOT test and an expert tuberculosis physician panel incorporating the Mantoux test a risk factor survey and a chest radiograph
Secondary Study Question
In a subset of patients who have tested positive on both the Mantoux and T-SPOT ELISPOT tests prior to undergoing additional immune suppression ie patients pre-bone marrow transplant and rheumatology patients pre-receipt of anti-TNF alpha therapy or high dose corticosteroids we propose to repeat the T-SPOT ELISPOT and Mantoux after immune suppression to assess the development of cutaneous anergy
We propose to investigate the correlation between the traditional TST-based method of screening for latent tuberculosis infection in specific immunocompromised populations as recommended by Canadian and American standards the T-SPOT TB ELISPOT test and an expert tuberculosis physician panel incorporating the Mantoux test a risk factor survey and a chest radiograph
Secondary Study Question
In a subset of patients who have tested positive on both the Mantoux and T-SPOT ELISPOT tests prior to undergoing additional immune suppression ie patients pre-bone marrow transplant and rheumatology patients pre-receipt of anti-TNF alpha therapy or high dose corticosteroids we propose to repeat the T-SPOT ELISPOT and Mantoux after immune suppression to assess the development of cutaneous anergy
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