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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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3 April 2017 |
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Main ID: |
ISRCTN85866583 |
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Date of registration:
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19/05/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Early diagnosis of invasive aspergillosis
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Scientific title:
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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) |
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Date of first enrolment:
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01/06/2005 |
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Target sample size:
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300 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN85866583 |
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Study type:
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Observational |
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Study design:
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Single centre observational diagnosis and validation of investigative/therapeutic process study (Diagnostic)
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Phase:
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Not Applicable
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Denise
Andrews |
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Address:
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Ground Floor, Pathology Block
St. Bartholomews Hospital
West Smithfield
EC1A 7BE
London
United Kingdom |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
Exclusion criteria: 1. Inability to give informed consent
2. Patients aged less than 18 years
3. Pre-existing chest disease
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Topic: National Cancer Research Network; Subtopic: Lung Cancer; Disease: Miscellaneous
Cancer
Lung cancer
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Intervention(s)
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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.
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Primary Outcome(s)
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GM ELISA from serum and BALF, measured within 6 months of the conclusion of the study
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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Gilead Sciences Inc (USA), Pfizer (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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