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Diagnostic Usefulness of Interferon Gamma Release Assay for Active Tuberculosis in Immunocompromised Patients

Primary Purpose

Tuberculosis

Status
Completed
Phase
Locations
Korea, Republic of
Study Type
Observational
Intervention
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Tuberculosis focused on measuring suspicious of tuberculosis, immunocompromised patients

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Yonsei Univ.

Arms of the Study

Arm 1

Arm 2

Arm Type

Arm Label

immunocompromised group

non-immunocompromised group

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 19, 2009
Last Updated
January 31, 2012
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT00962676
Brief Title
Diagnostic Usefulness of Interferon Gamma Release Assay for Active Tuberculosis in Immunocompromised Patients
Study Type
Observational

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
suspicious of tuberculosis, immunocompromised patients

7. Study Design

Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
immunocompromised group
Arm Title
non-immunocompromised group

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient suspicious of active tuberculosis with immunocompromised condition Immunocompromised condition patients with solid cancer with chemotherapy hematologic malignancy organ transplantation immunosuppressant ESRD on renal replacement therapy diabetes advanced liver cirrhosis Exclusion Criteria: Patients with less than 20 years who don't agree the participation of study hypersensitivity history to tuberculin pregnancy
Study Population Description
suspicious of tuberculosis, immunocompromised patients such cancer patients on chemotherapy, transplantation patients, patients with immunosuppressant
Sampling Method
Probability Sample
Facility Information:
Facility Name
Yonsei Univ.
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Diagnostic Usefulness of Interferon Gamma Release Assay for Active Tuberculosis in Immunocompromised Patients

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