Diagnostic and Management Strategies for Invasive Aspergillosis - Full Text View

Sponsored by:	King's College Hospital NHS Trust
Information provided by:	King's College Hospital NHS Trust
ClinicalTrials.gov Identifier:	NCT00816088

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

U.S. FDA Resources

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

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

Biospecimen Description:

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
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 3709 ext 3709	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

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

Keywords provided by King's College Hospital NHS Trust:

chemotherapy
Stem cell transplantation

Study placed in the following topic categories:

Mycoses
Neutropenia
Hematologic Diseases
Agranulocytosis

Leukocyte Disorders
Aspergillosis
Leukopenia
Granulocytopenia

ClinicalTrials.gov processed this record on January 16, 2009