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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00838643
Other study ID # Gal-01
Secondary ID
Status Active, not recruiting
Phase N/A
First received February 5, 2009
Last updated February 6, 2009
Start date May 2002
Est. completion date December 2009

Study information

Verified date February 2009
Source Ospedale Santa Croce-Carle Cuneo
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 220
Est. completion date December 2009
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria:

- Age > 16 years

- Allogeneic HSCT for a haematological disease

- Written informed consent to the study

Exclusion Criteria:

- Pediatric patients

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Italy Azienda Sanitaria Ospedaliera santa Croce e Carle Cuneo

Sponsors (1)

Lead Sponsor Collaborator
Ospedale Santa Croce-Carle Cuneo

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of invasive aspergillosis 1 year No
Secondary Clinical applicability of the EORTC/MSG criteria in a prospective multicenter trial 1 year No
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