Early diagnosis of invasive aspergillosis
| ISRCTN | ISRCTN85866583 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85866583 |
| Secondary identifying numbers | 2242 |
- Submission date
- 19/05/2010
- Registration date
- 19/05/2010
- Last edited
- 14/03/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
http://www.cancerhelp.org.uk/trials/a-trial-looking-at-2-new-tests-to-diagnose-a-fungal-infection
Contact information
Mrs Denise Andrews
Scientific
Scientific
Ground Floor, Pathology Block
St. Bartholomews Hospital
West Smithfield
London
EC1A 7BE
United Kingdom
Study information
| Study design | Single centre observational diagnosis and validation of investigative/therapeutic process study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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) |
| Study objectives | 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(s) | East London and the City Research Ethics Board, 01/06/2005, ref: 05/Q0603/68 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/06/2005 |
| Completion date | 31/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 300 |
| Key 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 |
| Key exclusion criteria | 1. Inability to give informed consent 2. Patients aged less than 18 years 3. Pre-existing chest disease |
| Date of first enrolment | 01/06/2005 |
| Date of final enrolment | 31/07/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Ground Floor, Pathology Block
London
EC1A 7BE
United Kingdom
EC1A 7BE
United Kingdom
Sponsor information
Barts and The London NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Queen Mary's Innovation Centre
5 Walden Street
London
E1 2EF
England
United Kingdom
| Website | http://www.bartsandthelondon.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/00b31g692 |
Funders
Funder type
Industry
Gilead Sciences Inc (USA)
No information available
Pfizer (UK)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Pfizer Inc., Pfizer Consumer Healthcare, Davis, Charles Pfizer & Company, Warner-Lambert, King Pharmaceuticals, Wyeth Pharmaceuticals, Seagen
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
14/03/2017: No publications found in PubMed, verifying study status with principal investigator
17/02/2011: The anticipated end date for this trial has been updated from 01/09/2008 to 31/07/2011
