Latent Tuberculosis Infection in Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00507754
Recruitment Status : Completed
First Posted : July 27, 2007
Last Update Posted : September 26, 2011
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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 or disease Intervention/treatment
Advanced Cancer Other: T-SPOT TB test

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Latent Mycobacterium Tuberculosis Infection Among Cancer Patients
Study Start Date : June 2007
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes Tuberculosis
U.S. FDA Resources

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. Rate of Positive Results of T-SPOT.TB (%) [ Time Frame: Study period 2 Years ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study participants with cancer at risk for developing active tuberculosis (TB).

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00507754

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

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00507754     History of Changes
Other Study ID Numbers: 2006-1095
First Posted: July 27, 2007    Key Record Dates
Last Update Posted: September 26, 2011
Last Verified: September 2011

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

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