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Latent Tuberculosis Infection in Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00507754
First received: July 25, 2007
Last updated: September 22, 2011
Last verified: September 2011
History of Changes
  Purpose

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:

  1. To examine the factors associated with positive response to T-SPOT.TB and the TST (tuberculin skin test) in patients with anergy.
  2. To determine the impact of immunosuppressive and antineoplastic therapy on the screening performance of T-SPOT.TB and the TST in cancer patients.

Condition Intervention
Advanced Cancer
 Other: T-SPOT TB test

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Latent Mycobacterium Tuberculosis Infection Among Cancer Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Rate of Positive Results of T-SPOT.TB (%) [ Time Frame: Study period 2 Years ] [ Designated as safety issue: No ]
    Number participants with postitive T-SPOT.TB test results compared to total positive results, derived from Center for Disease Control (CDC) Criteria used for LTBI positive skin test (i.e. a tuberculin skin test (TST) with 5 mm or more of induration). For those individuals with >5 mm induration on TST, chest radiograph performed. Fisher's exact test used to assess the association between categorical variables and the testing results of T-SPOT.TB or TST.


Biospecimen Retention:   Samples With DNA

A blood sample will be collected and used to perform the T-SPOT. TB test.


Enrollment: 24
Study Start Date: June 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Latent Tuberculosis Infection
Patients with cancer at risk for developing active tuberculosis (TB).
 Other: T-SPOT TB test
Extra blood draw, followed by ten minutes rest and the injection of Tuberculin subcutaneously on forearm.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Study participants with cancer at risk for developing active tuberculosis (TB).

Criteria

Inclusion Criteria:

  • Males and females.
  • Patients who are receiving chemotherapy for hematologic malignancy and solid-organ cancer.
  • Patients with a Hematopoietic stem cell transplantation (HSCT) history will be included after >1 year of transplantation.

Exclusion Criteria:

  • Refusal of consent
  • Individuals who, on the advice of the Primary or enrolling physician, may otherwise be at increased risk of an adverse reaction to venipuncture or tuberculin skin test administration.
  • Lymphocytopenia (< 300 cells/microliter)
  • Patients with known HIV infection.
  • Patients with known active tuberculosis will not be included in this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00507754

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Amar Safdar, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
UT MD Anderson Cancer Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00507754     History of Changes
Other Study ID Numbers: 2006-1095
Study First Received: July 25, 2007
Last Updated: September 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancer
Solid Tumors
Latent Mycobacterium Tuberculosis
Tuberculin Skin Test
 Tuberculosis
T-SPOT TB test
TB

Additional relevant MeSH terms:
Tuberculosis
Neoplasms
Latent Tuberculosis
Mycobacterium Infections
 Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 16, 2013