Diagnostic and Management Strategies for Invasive Aspergillosis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by King's College Hospital NHS Trust.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
King's College Hospital NHS Trust
Information provided by:
King's College Hospital NHS Trust
ClinicalTrials.gov Identifier:
NCT00816088
First received: December 30, 2008
Last updated: May 26, 2010
Last verified: August 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 King's College Hospital NHS Trust:
Primary Outcome Measures:
- To improve understanding of current clinical practice for diagnosis and management of IA. [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]
- To investigate and evaluate novel potential marker(s) for early diagnosis of Invasive Aspergillosis [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Evaluation of established and experimental diagnostic methods [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]
- Costing analysis [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]
- Establish the prognostic value of CT appearances in patients with IA [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]
- Assessing the value of methylene blue 'tattooing' prior to surgical biopsy [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Seum, Whole blood, urine, broncho-alveolar lavage, tissue
| Estimated Enrollment: | 200 |
| 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 |
|---|
|
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 |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00816088
Contacts
| Contact: M. Mansour Ceesay, FRCPath | +44 20 3299 9000 ext 4642 | mansour.ceesay@kch.nhs.uk |
| Contact: Antonio Pagliuca, FRCPath | +44 20 3299 3709 ext 3709 | tony.pagliuca@kch.nhs.uk |
Locations
| 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 | |
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
No publications provided by King's College Hospital NHS Trust
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Wendy Fisher, King's College Hospital NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT00816088 History of Changes |
| Other Study ID Numbers: | 08/H0808/154, 08HA11 |
| Study First Received: | December 30, 2008 |
| Last Updated: | May 26, 2010 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by King's College Hospital NHS Trust:
|
chemotherapy Stem cell transplantation |
Additional relevant MeSH terms:
|
Aspergillosis Neutropenia Mycoses Agranulocytosis |
Leukopenia Leukocyte Disorders Hematologic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013