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Study of Early Diagnosis of Invasive Aspergillosis Using Galactomannan ELISA and Real Time PCR in Patients at High Risk of Fungal Infection Due to Treatment for Hematologic Cancer or Other Diseases

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

No phase specified

Biomarker/Laboratory analysis, Diagnostic

Active

Over 18

Other, Pharmaceutical / Industry

BARTS-PECT2005
EU-20719, PFIZER-BARTS-PECT2005, SPRI-BARTS-PECT2005, GILEAD-BARTS-PECT2005, BARTS-05/Q0603/68, BARTS-PECT2005, NCT00462657

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.

Entry 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

Prior/Concurrent Therapy:

See Disease Characteristics

Patient Characteristics:

Not specified

Expected Enrollment

200

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

Outcomes

Primary Outcome(s)

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

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).

Trial Contact Information

Trial Lead Organizations

Saint Bartholomew's Hospital

Samir Agrawal, MD, PhD, Protocol chair
Ph: 44-207-601-8202
Email: s.g.agrawal@qmul.ac.uk

Trial Sites

United Kingdom

England

London

Royal Brompton Hospital

Mark Grifiths, MD
Ph: 44-20-7351-8523

Saint Bartholomew's Hospital

Samir Agrawal, MD, PhD
Ph: 44-207-601-8202

Email: s.g.agrawal@qmul.ac.uk

Registry Information

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

Trial Start Date		2005-07-06

Registered in ClinicalTrials.gov		NCT00462657

Date Submitted to PDQ		2007-03-13

Information Last Verified		2007-09-16

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.