Latent Tuberculosis Infection in Cancer Patients

NCT00507754 | Completed

• 1 other identifier: 2006-1095
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Cancer

Keywords

Advanced Cancer; Solid Tumors; Latent Mycobacterium Tuberculosis; Tuberculin Skin Test; Tuberculosis; T-SPOT TB test; TB

Outcome Measures

Primary Outcomes (1)

• Rate of Positive Results of T-SPOT.TB (%)

  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.

  Study period 2 Years

Study Arms (1)

Latent Tuberculosis Infection

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

Other: T-SPOT TB test

Interventions

T-SPOT TB test OTHER

Extra blood draw, followed by ten minutes rest and the injection of Tuberculin subcutaneously on forearm.

Latent Tuberculosis Infection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Amar Safdar, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2007
• First Posted: July 27, 2007
• Study Start: June 1, 2007
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: September 26, 2011

Record last verified: 2011-09

Locations

US (1)