Graft Versus Host DiseaseNCT00462657
Early Diagnosis of Aspergillosis in Patients at High Risk of Fungal Infection Caused by Treatment for Hematologic Cancer or Other Disease
A study testing polymerase chain reaction, bronchoalveolar lavage and immunoenzyme technique in people with Graft Versus Host Disease and Infection, run by St. Bartholomew's Hospital at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft Versus Host Disease, Infection, Leukemia
- What is being tested?
- polymerase chain reaction, bronchoalveolar lavage and immunoenzyme technique
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jul 2005to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Saint Bartholomew's Hospital
London, England, EC1A 7BE
Samir G Agrawal, MD, PhD, 44-207-601-8202, s.g.agrawal@qmul.ac.uk
- Recruiting
Royal Brompton Hospital
London, England, SW3 6NP
Mark Grifiths, MD, 44-20-7351-8523
About this study
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
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.
Read the 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.
- Conditions
- Graft Versus Host Disease, Infection, Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
- Being tested
- polymerase chain reaction, bronchoalveolar lavage, immunoenzyme technique, laboratory biomarker analysis, bronchoscopy
- Keywords
- 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
- Medical subject headings
- Graft vs Host Disease, Infections, Leukemia, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Congenital Abnormalities, Myeloproliferative Disorders, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polymerase chain reactionGenetic
bronchoalveolar lavageOther
immunoenzyme techniqueOther
laboratory biomarker analysisOther
bronchoscopyProcedure or surgery
management of therapy complicationsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2007 (estimated)
- Study startJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft Versus Host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Bartholomew's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Samir G Agrawal, MD, PhD, Study chair, St. Bartholomew's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00462657
- Sponsor's protocol ID
- CDR0000539539
- Other IDs
- BARTS-PECT2005, EU-20719, PFIZER-BARTS-PECT2005, SPRI-BARTS-PECT2005, GILEAD-BARTS-PECT2005, BARTS-05/Q0603/68
- Status last verified
- Sep 2007
- First submitted
- 18 Apr 2007
- Last updated
- 26 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00462657
- Acronym / sponsor ID
- CDR0000539539
- Conditions
- Graft Versus Host Disease, Infection, Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
- Keywords
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- St. Bartholomew's HospitalUniversity, hospital or other
- Study start
- Jul 2005
- First posted
- 19 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polymerase chain reaction | Genetic | – |
| bronchoalveolar lavage | Other | – |
| immunoenzyme technique | Other | – |
| laboratory biomarker analysis | Other | – |
| bronchoscopy | Procedure or surgery | – |
| management of therapy complications | Procedure or surgery | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
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Graft vs Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir G Agrawal, MD, PhD study chair
St. Bartholomew's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing polymerase chain reaction, bronchoalveolar lavage and immunoenzyme technique in people with Graft Versus Host Disease and Infection, run by St. Bartholomew's Hospital at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of galactomannan (GM) ELISA and real time PCR in detecting invasive aspergillosis (IA). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2013.