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Diagnostic and Management Strategies for Invasive Aspergillosis

This study has been completed.
Sponsor:
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
  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 23, 2017