Diagnostic Usefulness of Interferon Gamma Release Assay for Active Tuberculosis in Immunocompromised 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: NCT00962676
Recruitment Status : Completed
First Posted : August 20, 2009
Last Update Posted : February 2, 2012
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
For diagnosis of active tuberculosis, interferon-γ release assay based mycobacterium tuberculosis specific antigen may show higher sensitivity than tuberculin skin test in immunocompromised patients. Therefore, interferon-γ release assay have a role as a rapid diagnostic adjunctive methods for active tuberculosis in immunocompromised patients.

Condition or disease

Study Type : Observational
Actual Enrollment : 140 participants
Study Start Date : July 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis
U.S. FDA Resources

immunocompromised group
non-immunocompromised group

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
suspicious of tuberculosis, immunocompromised patients such cancer patients on chemotherapy, transplantation patients, patients with immunosuppressant

Inclusion Criteria:

  • Patient suspicious of active tuberculosis with immunocompromised condition
  • Immunocompromised condition patients with

    1. solid cancer with chemotherapy
    2. hematologic malignancy
    3. organ transplantation
    4. immunosuppressant
    5. ESRD on renal replacement therapy
    6. diabetes
    7. advanced liver cirrhosis

Exclusion Criteria:

  • Patients with

    1. less than 20 years
    2. who don't agree the participation of study
    3. hypersensitivity history to tuberculin
    4. pregnancy

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): NCT00962676

Korea, Republic of
Yonsei Univ.
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University

Responsible Party: Yonsei University Identifier: NCT00962676     History of Changes
Other Study ID Numbers: 4-2009-0129
First Posted: August 20, 2009    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: January 2012

Keywords provided by Yonsei University:
suspicious of tuberculosis
immunocompromised patients

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