Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00460330
Status:
UNKNOWN
Last Update Posted:
2007-04-13
First Post:
2007-04-11
Brief Title:
Evaluate Three Methods for Diagnosis of Invasive Fungal Infection in Chinese Patients After HSCT
Sponsor:
Peking University
Organization:
Peking University
Study Overview
Official Title:
The Value of Real-Time Polymerase Chain Reaction RT-PCR Assay Galactomannan and β-D-Glucan Detection GMG-Test for Diagnosis of Invasive Fungal Infection IFI in Chinese Patients After Hematopoietic Stem Cell Transplantation HSCT
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the cut-off value of GMG test in Chinese patients after hematopoietic stem cell transplantation and evaluate GMG test and real-time PCR for diagnosis of IFI in Chinese patients
Detailed Description:
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
GalactomannanGM is a cell wall component of aspergillus only which is released to the blood stream when the aspergillus grows While the β-D-glucanBG 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 GMG test by provenprobable IFI patients and negative controls Then we could calculate the sensitivity specificity positive and negative predict value of the GMG 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
GalactomannanGM is a cell wall component of aspergillus only which is released to the blood stream when the aspergillus grows While the β-D-glucanBG 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 GMG test by provenprobable IFI patients and negative controls Then we could calculate the sensitivity specificity positive and negative predict value of the GMG 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None