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
1 other identifier
observational
409
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2010
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2009
CompletedFirst Posted
Study publicly available on registry
November 26, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJuly 18, 2013
July 1, 2013
3.4 years
November 25, 2009
July 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
development of tuberculosis
after transplantation
Secondary Outcomes (1)
all cause mortality
after transplantation
Study Arms (1)
QFT (+) vs QFT (-)
Eligibility Criteria
Bone marrow transplant recipients
You may qualify if:
- Age 16 or more
- Bone marrow transplant recipients
You may not qualify if:
- Recent contact of patients with active pulmonary tuberculosis
- Suspected active tuberculosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asan Medical Center
Seoul, 138-736, South Korea
Related Publications (2)
Lee YM, Lee SO, Choi SH, Kim YS, Woo JH, Kim DY, Lee JH, Lee JH, Lee KH, Kim SH. A prospective longitudinal study evaluating the usefulness of the interferon-gamma releasing assay for predicting active tuberculosis in allogeneic hematopoietic stem cell transplant recipients. J Infect. 2014 Aug;69(2):165-73. doi: 10.1016/j.jinf.2014.02.019. Epub 2014 Mar 16.
PMID: 24647146DERIVEDMoon SM, Lee SO, Choi SH, Kim YS, Woo JH, Yoon DH, Suh C, Kim DY, Lee JH, Lee JH, Lee KH, Kim SH. Comparison of the QuantiFERON-TB Gold In-Tube test with the tuberculin skin test for detecting latent tuberculosis infection prior to hematopoietic stem cell transplantation. Transpl Infect Dis. 2013 Feb;15(1):104-9. doi: 10.1111/j.1399-3062.2012.00765.x. Epub 2012 Jul 23.
PMID: 22823749DERIVED
Biospecimen
whole blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sung-Han Kim, MD
Asan Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
November 25, 2009
First Posted
November 26, 2009
Study Start
January 1, 2010
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
July 18, 2013
Record last verified: 2013-07