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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00462657
First received: April 18, 2007
Last updated: August 23, 2013
Last verified: September 2007
  Purpose

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
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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Sensitivity and specificity of galactomannan (GM) ELISA and real time PCR in detecting invasive aspergillosis (IA) [ Designated as safety issue: No ]
  • Diagnostic value of IA screening by GM ELISA and real time PCR, in terms of positive and negative predicative values [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2005
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00462657

Locations
United Kingdom
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   
Sponsors and Collaborators
St. Bartholomew's Hospital
Investigators
Study Chair: Samir G Agrawal, MD, PhD St. Bartholomew's Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00462657     History of Changes
Other 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: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Neoplasms
Infection
Communicable Diseases
Graft vs Host Disease
Myelodysplastic Syndromes
Preleukemia
Aspergillosis
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Leukemia
Syndrome
Immune System Diseases
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Hyalohyphomycosis
Dermatomycoses
Skin Diseases, Infectious
Mycoses
Skin Diseases
Neoplasms by Histologic Type
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014