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Central nervous system disorders following hematopoietic stem cell transplantation: a prospective observational study from the Infectious Diseases Working Party (IDWP) and the Transplant Complications Working Party (TCWP)

Infectious Diseases Working Party (IDWP)
Transplant Complications Working Party (TCWP)
Study type:
Non-interventional Prospective Studies
Study number:
84140136
Type of Stem Cell Treatment:
Allogeneic
Autologous
Diseases:
Complications: infectious
Complications: non-infectious
Short title:
CNS Study
Primary objective:
- Clinical and diagnostic characteristics of infectious and non-infectious CNS disorders following allogeneic or autologous HSCT
- Outcome 30 days after CNS disorder onset (cured vs. improved vs. stabilized vs. worsened vs. died due to CNS disorder vs. died by other cause)
Key inclusion criteria:
All patients who undergo allogeneic or autologous HSCT between January 1st, 2021 and December 31st, 2022 and develop an infectious (any CTCAE grade) or relevant (CTCAE >1°) non-infectious CNS disorder after HSCT in this period
Country:
All European countries
Principal investigator:
Martin Schmidt-Hieber
EBMT Study coordinator:
Nina Knelange
Study coordinator email:
idwp.ebmt@lumc.nl
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
Medical data already reported to the EBMT Registry
Study Specific Questionnaire (MED-C)
Recipients who may access the data:
Leiden Study Unit
Statistical 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:
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