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| ID | Type | Description | Link |
|---|---|---|---|
| BARTS-PECT2005 | |||
| EU-20719 | |||
| PFIZER-BARTS-PECT2005 | |||
| SPRI-BARTS-PECT2005 | |||
| GILEAD-BARTS-PECT2005 | |||
| BARTS-05/Q0603/68 |
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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.
OBJECTIVES:
Primary
Secondary
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 (e.g., pH, hydrogen peroxide, and leukotriene B4).
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| polymerase chain reaction | Genetic | |||
| bronchoalveolar lavage | Other | |||
| immunoenzyme technique | Other | |||
| laboratory biomarker analysis | Other | |||
| bronchoscopy | Procedure | |||
| management of therapy complications | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of galactomannan (GM) ELISA and real time PCR in detecting invasive aspergillosis (IA) | ||
| Diagnostic value of IA screening by GM ELISA and real time PCR, in terms of positive and negative predicative values |
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DISEASE CHARACTERISTICS:
At high risk for developing invasive aspergillosis (IA) due to any of the following risk factors:
Diagnosis of acute myeloid leukemia, myelodysplastic syndromes, or acute lymphoblastic leukemia AND meets ≥ 1 of the following criteria:
Concurrent treatment with allogeneic hematopoietic stem cell transplantation (HSCT)
Requirement for high-dose steroids for graft-versus-host disease after HSCT
History of probable or proven IA and receiving chemotherapy
No preexisting chest disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Samir G Agrawal, MD, PhD | St. Bartholomew's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Bartholomew's Hospital | Recruiting | London | England | EC1A 7BE | United Kingdom |
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| Royal Brompton Hospital | Recruiting | London | England | SW3 6NP | United Kingdom |
|
| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| D007239 | Infections |
| D007938 | Leukemia |
| D009190 | Myelodysplastic Syndromes |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D000013 | Congenital Abnormalities |
| D009196 | Myeloproliferative Disorders |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007951 | Leukemia, Myeloid |
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| ID | Term |
|---|---|
| D016133 | Polymerase Chain Reaction |
| D018893 | Bronchoalveolar Lavage |
| D007124 | Immunoenzyme Techniques |
| D001999 | Bronchoscopy |
| ID | Term |
|---|---|
| D021141 | Nucleic Acid Amplification Techniques |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D007507 | Therapeutic Irrigation |
| D007118 | Immunoassay |
| D007158 | Immunologic Techniques |
| D007150 | Immunohistochemistry |
| D015336 | Molecular Probe Techniques |
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013510 | Pulmonary Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
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