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
- Diseases
- Childhood cancers
- 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
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Children's Hospital at Westmead Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
| Instituto de Cancerologia S.A Coordinator of this site? Confirm its status | Medellín | Colombia | Unknown status |
| Carl-Thiem-Klinikum Coordinator of this site? Confirm its status | Cottbus | Germany | Unknown status |
| Jena University Hospital Coordinator of this site? Confirm its status | Jena | Germany | Unknown status |
| University Children's Hospital Coordinator of this site? Confirm its status | Würzburg | Germany | Unknown status |
| Hospital Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Niño Jesus Children's Hospital Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Univ 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| University Hospital La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hopital St-Louis Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Central Hospital of Southern Pest Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Hadassah University Hospital Coordinator of this site? Confirm its status | Jarusalem | Israel | Unknown status |
| Ospedale San Martino Coordinator of this site? Confirm its status | Genova | Italy | Unknown status |
| Institute G. Gaslini Coordinator of this site? Confirm its status | Genova | Italy | Unknown status |
| Clinica di Oncoematologia Pediatrica Coordinator of this site? Confirm its status | Padova | Italy | Unknown status |
| Universita Cattolica S. Cuore Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| University Hospital, Collegium Medicum UMK Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Unknown status |
| University Children's Hospital in Krakow Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| The Medical University of Warsaw Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Raisa Gorbacheva Research Institute for Oncology Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Centre Ntl de greffe de MO de Tunis Coordinator of this site? Confirm its status | Tunis | Tunisia | Unknown status |
| Hacettepe University Children's Hospital Coordinator of this site? Confirm its status | Antalya | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.