Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462657
Status:
UNKNOWN
Last Update Posted:
2013-08-26
First Post:
2007-04-18
Brief Title:
Early Diagnosis of Aspergillosis in Patients at High Risk of Fungal Infection Caused by Treatment for Hematologic Cancer or Other Disease
Sponsor:
St Bartholomews Hospital
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Early Diagnosis of Invasive Aspergillosis in a High Risk Group of Patients Using Serum and Bronchoalveolar Lavage Fluid Real Time PCR and Galactomannan ELISA
Status:
UNKNOWN
Status Verified Date:
2007-09
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:
RATIONALE Studying ways to diagnose fungal infections early may help doctors plan the best treatment
PURPOSE This clinical trial is studying laboratory tests to see how well they find aspergillosis early in patients at high risk of fungal infection caused by treatment for hematologic cancer or other disease
PURPOSE This clinical trial is studying laboratory tests to see how well they find aspergillosis early in patients at high risk of fungal infection caused by treatment for hematologic cancer or other disease
Detailed Description:
OBJECTIVES
Primary
Determine the test characteristics of galactomannan GM ELISA using serum and bronchoalveolar lavage fluid BALF collected from patients at high risk of invasive fungal infection
Determine the test characteristics of aspergillus PCR using blood and BALF samples collected from these patients
Evaluate the role of noninvasive exhaled breath condensate EBC in detecting invasive aspergillosis IA
Determine whether repeated measures over time or a combination of markers improves the test characteristics
Establish cutoff points for the diagnosis of IA
Secondary
Determine the inflammatory marker and cytokine profile of EBC in fungal infection and after bone marrow transplantation as a marker of acute lung injury
Assess the role of bronchoscopy with bronchoalveolar lavage in identifying the causal pathogen early in the disease course of febrile neutropenic patients
Assess the role of GM ELISA in prognosis and response to treatment for IA
Assess the role of aspergillus PCR in prognosis and response to treatment for IA
OUTLINE This is a prospective study
Patients are assessed for early diagnosis of invasive aspergillosis IA using serum and bronchoalveolar lavage fluid BALF evaluated by ELISA for galactomannan GM antigen and real time PCR for fungal DNA Serum samples are collected at baseline and periodically during study beginning with the onset of neutropenia and continuing until resolution of fever or recovery of neutrophil count BALF samples are collected in patients with abnormal chest radiology evaluated by bronchoscopy and bronchoalveolar lavage BALF is analyzed for GM antigen fungal DNA inflammatory markers and cytokines
Patients are also assessed using exhaled breath condensate EBC evaluated by GM ELISA and real time PCR EBC is collected at baseline and periodically during study to detect GM antigen or fungal DNA and to measure markers of pulmonary inflammation and oxidative stress eg pH hydrogen peroxide and leukotriene B4
PROJECTED ACCRUAL A total of 200 patients will be accrued for this study
Primary
Determine the test characteristics of galactomannan GM ELISA using serum and bronchoalveolar lavage fluid BALF collected from patients at high risk of invasive fungal infection
Determine the test characteristics of aspergillus PCR using blood and BALF samples collected from these patients
Evaluate the role of noninvasive exhaled breath condensate EBC in detecting invasive aspergillosis IA
Determine whether repeated measures over time or a combination of markers improves the test characteristics
Establish cutoff points for the diagnosis of IA
Secondary
Determine the inflammatory marker and cytokine profile of EBC in fungal infection and after bone marrow transplantation as a marker of acute lung injury
Assess the role of bronchoscopy with bronchoalveolar lavage in identifying the causal pathogen early in the disease course of febrile neutropenic patients
Assess the role of GM ELISA in prognosis and response to treatment for IA
Assess the role of aspergillus PCR in prognosis and response to treatment for IA
OUTLINE This is a prospective study
Patients are assessed for early diagnosis of invasive aspergillosis IA using serum and bronchoalveolar lavage fluid BALF evaluated by ELISA for galactomannan GM antigen and real time PCR for fungal DNA Serum samples are collected at baseline and periodically during study beginning with the onset of neutropenia and continuing until resolution of fever or recovery of neutrophil count BALF samples are collected in patients with abnormal chest radiology evaluated by bronchoscopy and bronchoalveolar lavage BALF is analyzed for GM antigen fungal DNA inflammatory markers and cytokines
Patients are also assessed using exhaled breath condensate EBC evaluated by GM ELISA and real time PCR EBC is collected at baseline and periodically during study to detect GM antigen or fungal DNA and to measure markers of pulmonary inflammation and oxidative stress eg pH hydrogen peroxide and leukotriene B4
PROJECTED ACCRUAL A total of 200 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BARTS-05Q060368 | None | None | None |
| BARTS-PECT2005 | None | None | None |
| EU-20719 | None | None | None |
| PFIZER-BARTS-PECT2005 | None | None | None |
| SPRI-BARTS-PECT2005 | None | None | None |
| GILEAD-BARTS-PECT2005 | None | None | None |