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Diagnostic and Management Strategies for Invasive Aspergillosis
This study has been completed.
Sponsor:
King's College Hospital NHS Trust
Information provided by (Responsible Party):
Mansour Ceesay, King's College Hospital NHS Trust
ClinicalTrials.gov Identifier:
NCT00816088
First received: December 30, 2008
Last updated: December 22, 2014
Last verified: December 2014
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Purpose
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 |
|---|
| Invasive Aspergillosis Neutropenia |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
cyclic neutropenia
MedlinePlus related topics:
Aspergillosis
U.S. FDA Resources
Further study details as provided by Mansour Ceesay, King's College Hospital NHS Trust:
Primary Outcome Measures:
- To determine the incidence of IFD using a comprehensive diagnostic approach [ Time Frame: 3 years ]
Secondary Outcome Measures:
- Evaluation of established and experimental diagnostic methods [ Time Frame: 2-3 years ]
- Costing analysis [ Time Frame: 2-3 years ]
- Establish the prognostic value of CT appearances in patients with IA [ Time Frame: 2-3 years ]
- Assessing the value of methylene blue 'tattooing' prior to surgical biopsy [ Time Frame: 2-3 years ]
Biospecimen Retention: Samples With DNA
Seum, Whole blood, urine, broncho-alveolar lavage, tissue
| Enrollment: | 203 |
| Study Start Date: | December 2008 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
neutropenia
Patients undergoing stem cell transplantation or chemotherapy likely to lead to prolonged neutropenia.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Haemato-oncology patients undergoing high dose chemotherapy or stem cell transplantation likely to render them neutropenic.
Criteria
Inclusion Criteria:
- All adult haemato-oncology patients admitted for transplant or high dose chemotherapy and able to consent.
Exclusion Criteria:
- children (< 18 years old) or inability or refusal to consent.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00816088
Please refer to this study by its ClinicalTrials.gov identifier: NCT00816088
Locations
| United Kingdom | |
| King's College Hospital NHS Foundation Trust | |
| London, United Kingdom, SE5 9RS | |
Sponsors and Collaborators
King's College Hospital NHS Trust
Investigators
| 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 |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Mansour Ceesay, Clinical Research Fellow, King's College Hospital NHS Trust |
| ClinicalTrials.gov Identifier: | NCT00816088 History of Changes |
| Other Study ID Numbers: |
08/H0808/154 08HA11 |
| Study First Received: | December 30, 2008 |
| Last Updated: | December 22, 2014 |
Keywords provided by Mansour Ceesay, King's College Hospital NHS Trust:
|
chemotherapy Stem cell transplantation |
Additional relevant MeSH terms:
|
Neutropenia Aspergillosis Agranulocytosis Leukopenia Leukocyte Disorders Hematologic Diseases |
Hyalohyphomycosis Dermatomycoses Skin Diseases, Infectious Infection Mycoses Skin Diseases |
ClinicalTrials.gov processed this record on August 18, 2017