Early Diagnosis of Aspergillosis in Patients at High Risk of Fungal Infection Caused by Treatment for Hematologic Cancer or Other Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00462657
Recruitment Status : Unknown
Verified September 2007 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : April 19, 2007
Last Update Posted : August 26, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Graft Versus Host Disease Infection Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Genetic: polymerase chain reaction Other: bronchoalveolar lavage Other: immunoenzyme technique Other: laboratory biomarker analysis Procedure: bronchoscopy Procedure: management of therapy complications Not Applicable

Detailed Description:



  • 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.


  • 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 (e.g., pH, hydrogen peroxide, and leukotriene B4).

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Primary Purpose: 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
Study Start Date : July 2005

Primary Outcome Measures :
  1. Sensitivity and specificity of galactomannan (GM) ELISA and real time PCR in detecting invasive aspergillosis (IA)
  2. Diagnostic value of IA screening by GM ELISA and real time PCR, in terms of positive and negative predicative values

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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:

      • Receiving intensive chemotherapy with expected duration of neutropenia (ANC < 500/mm³) of > 10 days
      • Receiving high-dose steroids
    • 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


  • Not specified


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00462657

United Kingdom
Saint Bartholomew's Hospital Recruiting
London, England, United Kingdom, EC1A 7BE
Contact: Samir G Agrawal, MD, PhD    44-207-601-8202   
Royal Brompton Hospital Recruiting
London, England, United Kingdom, SW3 6NP
Contact: Mark Grifiths, MD    44-20-7351-8523      
Sponsors and Collaborators
St. Bartholomew's Hospital
Study Chair: Samir G Agrawal, MD, PhD St. Bartholomew's Hospital Identifier: NCT00462657     History of Changes
Other Study ID Numbers: CDR0000539539
First Posted: April 19, 2007    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: September 2007

Keywords provided by National Cancer Institute (NCI):
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)
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
de novo myelodysplastic syndromes
myelodysplastic/myeloproliferative neoplasm, unclassifiable
previously treated myelodysplastic syndromes
recurrent adult acute lymphoblastic leukemia
recurrent adult acute myeloid leukemia
secondary acute myeloid leukemia
secondary myelodysplastic syndromes
graft versus host disease

Additional relevant MeSH terms:
Communicable Diseases
Myelodysplastic Syndromes
Graft vs Host Disease
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Immune System Diseases
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases