Early diagnosis of invasive aspergillosis

Not Applicable

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Lung Cancer; Disease: Miscellaneous; Cancer; Lung cancer

• Registration Number: ISRCTN85866583
• Lead Sponsor: Barts and The London NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-19
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
GM ELISA from serum and BALF, measured within 6 months of the conclusion of the study

Secondary Outcome Measures

Name	Time	Method
Measured within 6 months of the conclusion of the study:<br>1. To establish cut off points to rule IA in or out<br>2. GM Elisa in prognosis<br>3. Inflamatory marker and cytokine profil in EBC<br>4. Non-invasive EBC in IA<br>5. PCR for Aspergillus<br>6. PCR for Aspergillus from blood and BALF<br>7. Repeated measures over time or a combination of markers<br>8. Role of BA