Latent Tuberculosis Infection in Bone Marrow Transplant Recipients

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: NCT01021124
Recruitment Status : Completed
First Posted : November 26, 2009
Last Update Posted : July 18, 2013
Information provided by (Responsible Party):
Sung-Han Kim, Asan Medical Center

November 25, 2009
November 26, 2009
July 18, 2013
January 2010
June 2013   (Final data collection date for primary outcome measure)
development of tuberculosis [ Time Frame: after transplantation ]
development of tuberculosis [ Time Frame: within 2 years after transplantation ]
Complete list of historical versions of study NCT01021124 on Archive Site
all cause mortality [ Time Frame: after transplantation ]
all cause mortality [ Time Frame: within 2 years after transplantation ]
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Latent Tuberculosis Infection in Bone Marrow Transplant Recipients
A Prospective Observational Study of Usefulness of a T Cell-based Assay for Latent Tuberculosis Infection in Hematopoietic Stem Cell Transplant Recipients
The aim of this study is to estimate the usefulness of a T cell-based assay (i.e. Quantiferon-Gold In-Tube assay) for diagnosis of latent tuberculosis infection (LTBI) in bone marrow transplant recipients. For this purpose, the investigators enrolled bone marrow transplant recipients and observed the developement of tuberculosis after the transplantation.

All adult bone marrow transplant recipients admitted to Asan Medical Center will be enrolled.

Quantiferon-Gold In-Tube assay will be performed.

Isoniazid prophylaxis will be given only to patients with clinical risk factors (i.e. recent contact with active pulmonary TB patient or inadequate treatment history with abnormal CXR). However, isoniazid prophylaxis will be not given based on positive TST or positive Quantiferon-Gold In-Tube assay.

Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
whole blood
Probability Sample
Bone marrow transplant recipients
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QFT (+) vs QFT (-)

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2013
June 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 16 or more
  • Bone marrow transplant recipients

Exclusion Criteria:

  • Recent contact of patients with active pulmonary tuberculosis
  • Suspected active tuberculosis
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
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Sung-Han Kim, Asan Medical Center
Asan Medical Center
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Principal Investigator: Sung-Han Kim, MD Asan Medical Center
Asan Medical Center
July 2013