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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.org
EBMT Study Unit:
Leiden Study Unit
Reason for processing personal data:
Research and Development of new and improved transplant, cell therapy and immunosuppression procedures.
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