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NCT04737785Completed

Central Nervous System Disorders Following Hematopoietic Stem Cell Transplantation

Central Nervous System Disorders Following Hematopoietic Stem Cell Transplantation: a Prospective Observational Trial From the Infectious Diseases Working Party and the Transplant Complications Working Party of the European Society for Blood and Marrow Transplantation

Source: ClinicalTrials.gov · Last updated 27 Aug 2024

Brief summary (registry, in English)

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 will identify clinical and diagnostic characteristics such as cerebrospinal fluid (CSF) and neuroimaging patterns, risk factors, response to treatment (including novel antifungal agents such as isavuconazole) and outcome. In addition, risk factors for CNS disorders after allogeneic and autologous HSCT will be analyzed using a prospectively assessed matched control group. In the future, this study might be the basis for an interventional trial (e.g. using a prophylactic approach).

Status (registry)
Completed
Study type
Observational
Enrollment
252 (actual)
First submitted
14 Jan 2021
Start date
Jan 2021
Primary completion date
Jun 2023
Lead sponsor
European Society for Blood and Marrow Transplantation
NCT number
NCT04737785

What you commit to

  • Study type: Observational
  • Participants enrolled: 252
  • From Jan 2021 to the primary completion date, Jun 2023
  • 22 sites in 12 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients not giving informed consent to report data to EBMT prior to initiation of transplant procedures

Other

  • Patients with missing essential Med-A data

Who the study is looking for

  • 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)

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (22)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Children's Hospital at Westmead
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WestmeadAustraliaUnknown status
Instituto de Cancerologia S.A
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MedellínColombiaUnknown status
Carl-Thiem-Klinikum
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CottbusGermanyUnknown status
Jena University Hospital
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JenaGermanyUnknown status
University Children's Hospital
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WürzburgGermanyUnknown status
Hospital Santa Creu i Sant Pau
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BarcelonaSpainUnknown status
Niño Jesus Children's Hospital
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MadridSpainUnknown status
Hospital Univ 12 de Octubre
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MadridSpainUnknown status
University Hospital La Fe
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ValenciaSpainUnknown status
Hopital St-Louis
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ParisFranceUnknown status
Central Hospital of Southern Pest
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BudapestHungaryUnknown status
Hadassah University Hospital
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JarusalemIsraelUnknown status
Ospedale San Martino
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GenovaItalyUnknown status
Institute G. Gaslini
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GenovaItalyUnknown status
Clinica di Oncoematologia Pediatrica
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PadovaItalyUnknown status
Universita Cattolica S. Cuore
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RomeItalyUnknown status
University Hospital, Collegium Medicum UMK
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BydgoszczPolandUnknown status
University Children's Hospital in Krakow
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KrakowPolandUnknown status
The Medical University of Warsaw
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WarsawPolandUnknown status
Raisa Gorbacheva Research Institute for Oncology
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Saint PetersburgRussiaUnknown status
Centre Ntl de greffe de MO de Tunis
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TunisTunisiaUnknown status
Hacettepe University Children's Hospital
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AntalyaTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.