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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00507754 |
Primary Objective:
1. To evaluate the performance of the new T-SPOT.TB test and the conventional TST for screening of Latent Tuberculosis infections in patients with cancer and those undergoing Hematopoietic Stem Cell Transplant.
Secondary Objectives:
Condition | Intervention |
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Advanced Cancer |
Device: T-SPOT TB test |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Latent Mycobacterium Tuberculosis Infection Among Cancer Patients |
A blood sample will be collected and used to perform the T-SPOT. TB test.
Estimated Enrollment: | 200 |
Study Start Date: | June 2007 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
Patients with cancer at risk for developing active tuberculosis (TB).
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Device: T-SPOT TB test
Extra blood draw, followed by ten minutes rest and the injection of Tuberculin subcutaneously on your forearm.
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TB AND TB TESTS:
Patients with cancer are considered "immunocompromised." This means that, because of the cancer and the cancer treatment, the immune system does not function normally, which decreases its ability to fight off infection and disease. This immunocompromised condition places these patients (who probably had been in contact with the TB bacteria, resulting in latent, or inactive, TB) at risk for active TB. Latent TB does not cause symptoms or signs of active TB infection. It is very important to identify patients who are at risk for developing active TB, so that they can receive timely treatment for TB.
The Tuberculin skin test (TST) is currently used to detect latent TB. The TST is considered to have low detection sensitivity, which means that it may not always detect latent TB, which may then turn into an active TB infection.
The T-SPOT.TB is a new test that researchers want to study to see whether it may be more effective and accurate than the TST at identifying patients at risk for developing active TB.
STUDY PARTICIPATION:
If you agree to take part in this study, you will have the following tests done and steps taken.
If you have had a TST (or tuberculin skin test) performed at M. D. Anderson in the past 45 days, it may probably not be necessary to repeat the TST. However, the research staff will decide if you need to have a new TST.
You may have the TST performed before or after your blood is drawn. In any case, you will rest for 10 minutes after the blood draw.
Although you will be informed about the TST result, you will not be informed about the T-SPOT. TB test result because the T-SPOT. TB test is just used for investigational purposes in this study and will not be used for diagnostic purposes. The study doctor will use the results of the T-SPOT. TB test to make research comparisons with the TST test results.
LENGTH OF STUDY:
Your participation will be over in this study once both TB tests have been performed and the TST has been checked by a health care professional.
This is an investigational study. The TST is FDA approved and commercially available. The T-SPOT.TB test is not FDA approved or commercially available. It is authorized for use in research only. Up to 200 patients will take part in this study. All will be enrolled at M. D. Anderson.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Study participants with cancer at risk for developing active tuberculosis (TB).
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
U.T.M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Amar Safdar, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Amar Safdar, MD/Associate Professor ) |
Study ID Numbers: | 2006-1095 |
Study First Received: | July 25, 2007 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00507754 |
Health Authority: | United States: Institutional Review Board |
Advanced Cancer Solid Tumors Latent Mycobacterium Tuberculosis Tuberculin Skin Test |
Tuberculosis T-SPOT TB test TB |
Bacterial Infections Gram-Positive Bacterial Infections Mycobacterium Infections Tuberculosis |
Actinomycetales Infections |