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Invasive Aspergillosis After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Ospedale Santa Croce-Carle Cuneo.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00838643
First Posted: February 6, 2009
Last Update Posted: February 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ospedale Santa Croce-Carle Cuneo
  Purpose
Evaluation of incidence of invasive aspergillosis in patients who have undergone an allogeneic stem cell transplantation, with particular regard to the role of galactomannan assay and of early TC scan in asymptomatic patients.

Condition
Hematological Diseases Invasive Aspergillosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence of Invasive Aspergillosis in Allogeneic Stem Cell Transplantation Patients: an Italian Prospective Multicentre Study

Resource links provided by NLM:


Further study details as provided by Ospedale Santa Croce-Carle Cuneo:

Primary Outcome Measures:
  • Incidence of invasive aspergillosis [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Clinical applicability of the EORTC/MSG criteria in a prospective multicenter trial [ Time Frame: 1 year ]

Enrollment: 220
Study Start Date: May 2002
Estimated Study Completion Date: December 2009
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
Allogeneic pts
Adult allogeneic HSCT recipients

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients given allogeneic HSCT in tertiary care centers or university hospitals in Piedmont
Criteria

Inclusion Criteria:

  • Age > 16 years
  • Allogeneic HSCT for a haematological disease
  • Written informed consent to the study

Exclusion Criteria:

  • Pediatric patients
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00838643


Locations
Italy
Azienda Sanitaria Ospedaliera santa Croce e Carle
Cuneo, Italy, 12100
Sponsors and Collaborators
Ospedale Santa Croce-Carle Cuneo
  More Information

Responsible Party: Nicola Mordini, Ospedale Santa Croce-Carle Cuneo
ClinicalTrials.gov Identifier: NCT00838643     History of Changes
Other Study ID Numbers: Gal-01
First Submitted: February 5, 2009
First Posted: February 6, 2009
Last Update Posted: February 9, 2009
Last Verified: February 2009

Keywords provided by Ospedale Santa Croce-Carle Cuneo:
allogeneic transplantation
Invasive aspergillosis

Additional relevant MeSH terms:
Aspergillosis
Hematologic Diseases
Mycoses
Hyalohyphomycosis
Dermatomycoses
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases