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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Brief Summary

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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.

Detailed Description

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

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

Conditions

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Graft Versus Host Disease Infection Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms

Keywords

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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) 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

Study Design

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Primary Study Purpose

DIAGNOSTIC

Interventions

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polymerase chain reaction

Intervention Type GENETIC

bronchoalveolar lavage

Intervention Type OTHER

immunoenzyme technique

Intervention Type OTHER

laboratory biomarker analysis

Intervention Type OTHER

bronchoscopy

Intervention Type PROCEDURE

management of therapy complications

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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:

* 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

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Samir G Agrawal, MD, PhD

Role: STUDY_CHAIR

St. Bartholomew's Hospital

Locations

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Saint Bartholomew's Hospital

London, England, United Kingdom

Site Status RECRUITING

Royal Brompton Hospital

London, England, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Facility Contacts

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Samir G Agrawal, MD, PhD

Role: primary

Mark Grifiths, MD

Role: primary