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Sponsored by: |
St. Bartholomew's Hospital |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00462657 |
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.
Condition | Intervention |
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Cancer |
Procedure: bronchoalveolar lavage Procedure: bronchoscopy Procedure: immunoenzyme technique Procedure: laboratory biomarker analysis Procedure: management of therapy complications Procedure: polymerase chain reaction |
Study Type: | Interventional |
Study Design: | Diagnostic |
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 |
Estimated Enrollment: | 200 |
Study Start Date: | July 2005 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United Kingdom, England | |
Royal Brompton Hospital | Recruiting |
London, England, United Kingdom, SW3 6NP | |
Contact: Mark Grifiths, MD 44-20-7351-8523 | |
Saint Bartholomew's Hospital | Recruiting |
London, England, United Kingdom, EC1A 7BE | |
Contact: Samir G Agrawal, MD, PhD 44-207-601-8202 s.g.agrawal@qmul.ac.uk |
Study Chair: | Samir G Agrawal, MD, PhD | St. Bartholomew's Hospital |
Study ID Numbers: | CDR0000539539, BARTS-PECT2005, EU-20719, PFIZER-BARTS-PECT2005, SPRI-BARTS-PECT2005, GILEAD-BARTS-PECT2005, BARTS-05/Q0603/68 |
Study First Received: | April 18, 2007 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00462657 |
Health Authority: | Unspecified |
infection adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) accelerated phase chronic myelogenous leukemia adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission atypical chronic myeloid leukemia blastic phase chronic myelogenous leukemia chronic eosinophilic leukemia chronic idiopathic myelofibrosis chronic myelomonocytic leukemia chronic neutrophilic leukemia |
chronic phase chronic myelogenous leukemia de novo myelodysplastic syndromes disseminated neuroblastoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue myelodysplastic/myeloproliferative disease, unclassifiable nodal marginal zone B-cell lymphoma noncontiguous stage II adult Burkitt lymphoma noncontiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse mixed cell lymphoma noncontiguous stage II adult diffuse small cleaved cell lymphoma noncontiguous stage II adult immunoblastic large cell lymphoma noncontiguous stage II adult lymphoblastic lymphoma noncontiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma noncontiguous stage II grade 3 follicular lymphoma |
Blast Crisis Sezary syndrome Chronic myelogenous leukemia Chronic myelomonocytic leukemia Graft versus host disease Hodgkin lymphoma, adult Lymphoma, Mantle-Cell Lymphoma, small cleaved-cell, diffuse Ovarian epithelial cancer Lymphoma, large-cell, immunoblastic Mycoses Preleukemia Multiple myeloma Leukemia, Lymphocytic, Chronic, B-Cell Neoplasm Metastasis |
Acute myeloid leukemia, adult Hodgkin Disease Chronic lymphocytic leukemia Myelodysplastic syndromes Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Leukemia, B-cell, chronic Leukemia, Myelomonocytic, Chronic Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Acute myelogenous leukemia Myeloproliferative Disorders Breast Neoplasms Leukemia, Myeloid Testicular Neoplasms |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |