Status:
COMPLETED
Central Nervous System Disorders Following Hematopoietic Stem Cell Transplantation
Lead Sponsor:
European Society for Blood and Marrow Transplantation
Conditions:
Central Nervous System Infections
Central Nervous System Complication
Eligibility:
All Genders
Brief Summary
All patients undergoing allogeneic or autologous HSCT at the participating centres will be observed. Once a diagnosis of CNS disorder is made, additional data will be reported for these patients. We ...
Detailed Description
For each case patient (i.e. HSCT recipient with a CNS disorder) two control patients (1:2 allocation) should be analysed prospectively with the aim to get more insights into risk factors for CNS disor...
Eligibility Criteria
Inclusion
- Case group:
- received allogeneic or autologous HSCT between January 1st, 2021 and December 31st, 2022
- develop an infectious (any CTCAE grade) or relevant (CTCAE \>1°) non-infectious CNS disorder after HSCT in this period.
- Control group:
- received allogeneic or autologous HSCT between January 1st, 2021 and February 28th, 2023
- who survive and do not develop a CNS disorder until the inclusion time point (day 0, defined as the same delay between transplantation and CNS disorder onset of the corresponding case)
Exclusion
- Patients with missing essential Med-A data
- Patients not giving informed consent to report data to EBMT prior to initiation of transplant procedures
Key Trial Info
Start Date :
January 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2024
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT04737785
Start Date
January 1 2021
End Date
August 1 2024
Last Update
August 27 2024
Active Locations (22)
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1
The Children's Hospital at Westmead
Westmead, Australia
2
Instituto de Cancerologia S.A
Medellín, Colombia
3
Hopital St. Louis
Paris, France, 75010
4
Carl-Thiem-Klinikum
Cottbus, Germany