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
Sponsor:
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
  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:


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 April 17, 2014