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Sponsored by: |
King's College Hospital NHS Trust |
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Information provided by: | King's College Hospital NHS Trust |
ClinicalTrials.gov Identifier: | NCT00816088 |
Fungal infections caused by Aspergillus fumigatus are now identified in up to 45% of patients dying from haematological malignancy. There has been a significant increase in deaths from IA over the last 20 years. Our current diagnostic approach is neither sensitive nor specific. The purpose of this study is to prospectively assess the value of current diagnostic tools, as well as test other new diagnostic methods for the diagnosis of IA among haemato-oncology patients undergoing chemotherapy or stem cell transplantation.
Condition |
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Invasive Aspergillosis Neutropenia |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Diagnostic and Management Strategies for Invasive Aspergillosis in Neutropenic Adult Haemato-Oncology Patients With a Proposal for Investigation of a Novel Potential Marker for Early Diagnosis: a Prospective Cohort Study |
Seum, Whole blood, urine, broncho-alveolar lavage, tissue
Estimated Enrollment: | 300 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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neutropenia
Patients undergoing stem cell transplantation or chemotherapy likely to lead to prolonged neutropenia.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Haemato-oncology patients undergoing high dose chemotherapy or stem cell transplantation likely to render them neutropenic.
Inclusion Criteria:
Exclusion Criteria:
Contact: M. Mansour Ceesay, FRCPath | +44 20 3299 3709 ext 3709 | mansour.ceesay@kch.nhs.uk |
Contact: Antonio Pagliuca, FRCPath | +44 20 3299 3709 ext 3709 | tony.pagliuca@kch.nhs.uk |
United Kingdom | |
King's College Hospital NHS Foundation Trust | Recruiting |
London, United Kingdom, SE5 9RS | |
Principal Investigator: Antonio Pagliuca, FRCPath | |
Principal Investigator: M. Mansour Ceesay, FRCPath |
Principal Investigator: | M.Mansour Ceesay, FRCPath | Kings College Hospital |
Principal Investigator: | Antonio Pagliuca, FRCPath | Kings College Hospital |
Principal Investigator: | Jim Wade, FRCPath | Kings College Hospital |
Principal Investigator: | Melvyn Smith, PhD | Kings College Hospital |
Principal Investigator: | Sujal Desai, FRCR | Kings College Hospital |
Responsible Party: | King's College Hospital NHS Foundation Trust ( Wendy Fisher ) |
Study ID Numbers: | 08/H0808/154, 08HA11 |
Study First Received: | December 30, 2008 |
Last Updated: | December 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00816088 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
chemotherapy Stem cell transplantation |
Mycoses Neutropenia Hematologic Diseases Agranulocytosis |
Leukocyte Disorders Aspergillosis Leukopenia Granulocytopenia |