This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Latent Tuberculosis Infection in Bone Marrow Transplant Recipients

This study has been completed.
Information provided by (Responsible Party):
Sung-Han Kim, Asan Medical Center Identifier:
First received: November 25, 2009
Last updated: July 17, 2013
Last verified: July 2013
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.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study of Usefulness of a T Cell-based Assay for Latent Tuberculosis Infection in Hematopoietic Stem Cell Transplant Recipients

Resource links provided by NLM:

Further study details as provided by Sung-Han Kim, Asan Medical Center:

Primary Outcome Measures:
  • development of tuberculosis [ Time Frame: after transplantation ]

Secondary Outcome Measures:
  • all cause mortality [ Time Frame: after transplantation ]

Biospecimen Retention:   Samples Without DNA
whole blood

Enrollment: 409
Study Start Date: January 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
QFT (+) vs QFT (-)

Detailed Description:

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.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Bone marrow transplant recipients

Inclusion Criteria:

  • Age 16 or more
  • Bone marrow transplant recipients

Exclusion Criteria:

  • Recent contact of patients with active pulmonary tuberculosis
  • Suspected active tuberculosis
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01021124

Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Principal Investigator: Sung-Han Kim, MD Asan Medical Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sung-Han Kim, Assistant Professor, Asan Medical Center Identifier: NCT01021124     History of Changes
Other Study ID Numbers: 2009-0077
Study First Received: November 25, 2009
Last Updated: July 17, 2013

Keywords provided by Sung-Han Kim, Asan Medical Center:
bone marrow transplant

Additional relevant MeSH terms:
Latent Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections processed this record on September 21, 2017