Plain English Summary
http://www.cancerhelp.org.uk/trials/a-trial-looking-at-2-new-tests-to-diagnose-a-fungal-infection
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2242
Study information
Scientific title
Early diagnosis of invasive aspergillosis in a high risk group of patients using serum and bronchoalveolar lavage fluid, real time polymerase chain reaction (PCR) and galactomannan enzyme-linked immunosorbent assay (ELISA)
Acronym
Study hypothesis
The aim of the study is to determine characteristics for two diagnostics tests in invasive aspergillosis (IA) in patients at high risk with neutropenia following intensive chemotherapy or allogenic bone marrow transpant.
Ethics approval
East London and the City Research Ethics Board, 01/06/2005, ref: 05/Q0603/68
Study design
Single centre observational diagnosis and validation of investigative/therapeutic process study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: National Cancer Research Network; Subtopic: Lung Cancer; Disease: Miscellaneous
Intervention
Study interventions will begin prior to the start of chemo/immunosuppression and continue until recovery of the neutrophil count to greater than 1.0 x 10^9/L. If fungal infection occurs, then testing should continue until discharge. Samples will be analysed in batches. A febrile episode is defined as any of the following:
1. Temperature greater than 38°C for more than 4 hours
2. Temperature greater than 38°C on two occassions greater than 4 hours apart within a 24 hour period
3. Temp greater than 38.5°C on one occassion
PCR: PCR for fungal DNA will be performed twice weekly.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
GM ELISA from serum and BALF, measured within 6 months of the conclusion of the study
Secondary outcome measures
Measured within 6 months of the conclusion of the study:
1. To establish cut off points to rule IA in or out
2. GM Elisa in prognosis
3. Inflamatory marker and cytokine profil in EBC
4. Non-invasive EBC in IA
5. PCR for Aspergillus
6. PCR for Aspergillus from blood and BALF
7. Repeated measures over time or a combination of markers
8. Role of BAL
Overall trial start date
01/06/2005
Overall trial end date
31/07/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Informed consent
2. Patients with acute myeloid leukemia (AML), myelodysplastic syndromes (MDS) and acute lymphoblastic leukemia (ALL) undergoing intensive chemotherapy (predicted neutropenia of less than 0.5 x 10^9/L for greater than 10 days) and/or receiving high dose steroids
3. Patients undergoing allogeneic haematopoietic stem cell transplantation (HSCT)
4. Patients requiring high dose steroids for graft versus host disease post HSCT
5. Patients with a history of probable or proven invasive aspergillosis and having chemotherapy, regardless of their underlying haematological malignancy
6. Aged greater than 18 years, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 300
Participant exclusion criteria
1. Inability to give informed consent
2. Patients aged less than 18 years
3. Pre-existing chest disease
Recruitment start date
01/06/2005
Recruitment end date
31/07/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Ground Floor, Pathology Block
London
EC1A 7BE
United Kingdom
Sponsor information
Organisation
Barts and The London NHS Trust (UK)
Sponsor details
Queen Mary's Innovation Centre
5 Walden Street
London
E1 2EF
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Gilead Sciences Inc (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Pfizer (UK)
Alternative name(s)
Pfizer Inc.
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list