Infectious Diseases Working Party (IDWP)
Study type:
Study number:
84140148
Type of Stem Cell Treatment:
Allogeneic
Diseases:
Complications: infectious
Short title:
Primary objective:
1) to describe the clinical, radiological and microbiological characteristics of Fusarium infections in allo-HCT patients;
2) to identify risk factors for Fusarium infections in allo-HCT patients, including antifungal prophylaxis.
Secondary objectives:
1) to assess the clinical outcome after Fusarium infection (all-cause mortality at 6 weeks);
2) to assess risk factors associated with mortality after Fusarium infection
3) to assess incidence of invasive fusariosis
2) to identify risk factors for Fusarium infections in allo-HCT patients, including antifungal prophylaxis.
Secondary objectives:
1) to assess the clinical outcome after Fusarium infection (all-cause mortality at 6 weeks);
2) to assess risk factors associated with mortality after Fusarium infection
3) to assess incidence of invasive fusariosis
Key inclusion criteria:
All allogeneic HSCT recipients who developed proven or probable Fusarium infection between 01 January 2010 and 31 May 2023 (irrespective of patient age, underlying disease or transplant date).
Country:
All EBMT member countries
Principal investigator:
Dina Averbuch
EBMT Study coordinator:
Lotus Wendel
Study coordinator email:
idwp.ebmt@lumc.nl
EBMT Study Unit:
Leiden Study Unit
Reason for processing personal data:
Patients’ data is needed to be able to identify the patient and calculate age at any time (impact on SAEs and response to clinical medications). Health care personal data is part of the CV collected for evidence of proper qualification for running the trial.
Categories of personal data collected:
DOB/YOB, gender
Study Specific Questionnaire (MED-C)
Recipients who may access the data:
Leiden Study Unit
3rd-party processors of Personal Data on behalf of EBMT/Service provider:
No
Privacy notices
Article 6 lawful basis for processing personal data:
Article 6.1 (a) - Consent (Collection)
Article 9 basis for processing special category data:
Article 9(2) (a) - Consent (Collection)
Data Protection Impact Assessments
Rights available to individuals:
Access
Data portability
Rectification
Objection
Deletion
Is a Data Protection Impact Assessment required?:
DPIA performed for EBMT Registry (WP & NIS Studies)
Retention Schedule (if possible):
at least 5 years after the final report or first publication of study results