Hematopoietic Stem Cell Transplantation Clinical Trial
Official title:
The Value of Real-Time Polymerase Chain Reaction (RT-PCR) Assay, Galactomannan and β-D-Glucan Detection (GM/G-Test) for Diagnosis of Invasive Fungal Infection (IFI) in Chinese Patients After Hematopoietic Stem Cell Transplantation (HSCT)
The purpose of this study is to assess the cut-off value of GM/G test in Chinese patients after hematopoietic stem cell transplantation, and evaluate GM/G test and real-time PCR for diagnosis of IFI in Chinese patients.
Invasive fungal infection is one of the major complications of HSCT recipients, and the
incidence is increased rapidly in recent years. IFI also commonly occurs in Chinese HSCT
recipients, and there is no formal report on the mortality and morbidity of IFI in Chinese
patients, so this study could supply these data.
Galactomannan(GM) is a cell wall component of aspergillus only, which is released to the
blood stream when the aspergillus grows. While the β-D-glucan(BG) is in the most fungal cell
wall, and the high level of BG in body fluid is also an evidence of fungal infection. In this
study, the serum level of GM and BG would be detected by the commercial available kit.
We will assess the cut-off value of GM/G test by proven/probable IFI patients and negative
controls. Then, we could calculate the sensitivity, specificity, positive and negative
predict value of the GM/G test. Meanwhile, we may find out the genus of the fungus by
comparison of the two methods. For example, both positive of GM and G-test may suggest that
the pathogen is Aspergillus, while the positive G-test and negative GM-test implies the
Candida may be the pathogen.
RT-PCR is also a helpful method for the IFI diagnosis, which is more sensitive than GM and
G-test and encompassing multiple fungal genera. The small-subunit rRNA gene sequence is
relatively conserved among members of fungal kingdom, including the Aspergillus and Candida
species, the dimorphic fungi, the agents of zygomycosis, and Pneumocystis. So we will amplify
that part of DNA and using gene specific probe to detect whether the sample is positive for
fungus or not. Until now, there is no report about real-time PCR assay for diagnosis of IFI
in Chinese HSCT recipients, so we want to carry out this study. At the same time, the result
of real-time PCR assay could help us to estimate the coincidence of GM and G-test with the
IFI patients.
After performing the above three diagnostic test, we could identify the HSCT recipients
whether they have the IFI more accurately, so that we could evaluate the antifungal therapy
and find out the risk factors for IFI in those patients more accurately.
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