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| Name | Class |
|---|---|
| Schweizerische Multiple Sklerose Gesellschaft | OTHER |
| Insel Gruppe AG, University Hospital Bern | OTHER |
| Novartis | INDUSTRY |
| Anna Mueller Grocholski-Stiftung |
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The Swiss-Ped-IBrainD is a national patient registry that collects information on diagnosis, symptoms, treatment, and follow-up of pediatric patients with an inflammatory brain disease in Switzerland. It was first implemented in 2020 in the pediatric clinic of the university hospital in Bern. Further centers all over Switzerland opened for recruitment after that: Aarau, Basel, Bellinzona, Chur, Geneva, Lausanne, Lucerne, St. Gallen, Winterthur and Zurich. The center in Fribourg is expected open for recruitment in 2025. The registry provides data for national and international monitoring and research. It supports research on inflammatory brain diseases in Switzerland and the exchange of knowledge between clinicians, researchers, and therapists. The registry aims to improve the treatment of children with inflammatory brain diseases and optimizing their health care and quality of life.
Background:
Pediatric onset MS and other inflammatory brain diseases (IBrainDs) are severe diseases affecting children and adolescents in a period of essential brain development. This possibly leads to a variety of focal neurological deficits as well as early cognitive impairment. In turn, the cognitive impairment may impact school performance and vocational achievements.
Timely diagnosis and treatment initiation as well as individually tailored management are important for a favorable disease course. However, the diagnosis of the different IBrainDs can be challenging, especially in young children, since their first acute inflammation is often accompanied by unspecific symptoms common to all IBrainDs. A systematic assessment of similarities and differences between clinical signs, symptoms, and diagnostic workup of different IBrainDs will enable faster and more reliable diagnosis.
Furthermore, neither epidemiological data nor information on health care management and disease outcome of pediatric IBrainD patients exist in Switzerland. Therefore, a national registry is being established, which will allow a deeper understanding of pediatric IBrainD epidemiology, clinical presentation, and management. Ultimately, the registry will improve the care of children suffering from an IBrainD in Switzerland.
The Swiss-Ped-IBrainD Registry (title: "Swiss Pediatric Inflammatory Brain Disease Cohort Study", project number: 2019-00377) has been approved by the ethics committees of Bern, the Ethikkommission Nordwest- und Zentralschweiz (EKNZ), the Ethikkommission Ostschweiz (EKOS), and the ethics committees of Zürich, Lausanne, Geneva, and Bellinzona.
Objectives:
The registry pursues the following goals:
The registry thus addresses the increasing requests for medical trial participation and promotes the exchange with existing adult registries (e.g., Swiss MS Registry).
Inclusion/exclusion criteria:
All patients living and/or treated in Switzerland with an IBrainD specified in the following list diagnosed from 2005 onward and with a disease onset before the age of 18.
Excluded are patients with:
Registration of Patients and Collection of Medical Data:
Pediatricians, pediatric neurologists, neurologists, specialists in rehabilitation, and primary care physicians at the participating centers are responsible to identify children with the listed IBrainDs during regular medical consultations. Upon identification, treating physicians inform patients and their parents orally and in writing about the Swiss-Ped-IBrainD. Patients (and their legal representatives if applicable) who want to participate must give their informed consent. Once a patient consents to participate, their medical data will be entered in the registry.
The diagnostic workup and treatment of patients continue as usual and are independent from participation; no examination will be carried out specifically for the Swiss-Ped-IBrainD.
Medical data is collected through the following sources:
Routine data and linkages:
Communities; Federal Statistical Office (e.g. the birth register, cause of death statistics, hospital statistics)
Current status:
Since 2020, the investigators have included 128 people diagnosed with an IBrainD.
Funding:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient population | Children, adolescents and adults diagnosed with an IBrainD from 2005 onward and with disease onset before age 18, who are born, treated or living in Switzerland |
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| Measure | Description | Time Frame |
|---|---|---|
| Personal data | Registering patient's personal data | At registration (Life-long; Up to 80 years) |
| Diagnosis | Diagnosis of IBrainD | Until reaching of adulthood (0 to 18 years) |
| Age at diagnosis | Age at diagnosis (months and years) | Until reaching of adulthood (0 to 18 years) |
| First symptoms | Symptoms before diagnosis | Until reaching of adulthood (0 to 18 years) |
| Age at first symptoms | Age at first symptoms | Until reaching of adulthood (0 to 18 years) |
| Diagnostic delay | Time elapsed between symptom-onset and diagnosis (days) | Until reaching of adulthood (0 to 18 years) |
| Hospitalization | Length of hospitalization at diagnosis or during a relapse (days) | Until reaching of adulthood (0 to 18 years) |
| Rehabilitation | Length and type of rehabilitation at diagnosis or during a relapse (days) | Until reaching of adulthood (0 to 18 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Future questionnaires | Data from validated instrument such as the Pediatric Quality of Life Inventory (PedsQL); Scale from 0-100, where 100 is the best possible outcome and 0 the worst possible outcome. | Life-long; Up to 80 years; Will mainly concern childhood (until reaching of adulthood; 0 to 18 years) |
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Inclusion Criteria:
All patients living and/or treated in Switzerland with an IBrainD specified in the following list diagnosed from 2005 onward and with a disease onset before the age of 18.
Exclusion Criteria:
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All patients living and/or treated in Switzerland with a listed IBrainD diagnosed from 2005 onward and a disease onset before the age of 18.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lorena F Hulliger, MSc | Contact | +41316845678 | lorena.hulliger@unibe.ch |
| Name | Affiliation | Role |
|---|---|---|
| Sandra Bigi, PD MD | ISPM, University of Bern, Bern; Kinderspital Zentralschweiz, Luzern | Principal Investigator |
| Sandra Bigi, PD MD | ISPM, University of Bern, Bern Kinderspital Zentralschweiz, Luzern | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Aarau | Recruiting | Aarau | Canton of Aargau | 5001 | Switzerland |
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| Label | URL |
|---|---|
| Website of the registry | View source |
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Researchers who wish to develop a nested study need to submit a proposal to the Swiss-Ped-IBrainD committee and request permission. A concept sheet describing the planned analyses must be approved by the Swiss-Ped-IBrainD committee. Nested studies might need separate ethics permission.
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| UNKNOWN |
| Gottfried und Julia Bangerter- Rhyner-Stiftung, Basel | OTHER |
| Biogen | INDUSTRY |
| Roche Pharma (Switzerland) Ltd | UNKNOWN |
| Fondation Johanna Dürmüller-Bol | UNKNOWN |
| Kantonsspital Aarau | OTHER |
| University Children's Hospital Basel | OTHER |
| Ente Ospedaliero Cantonale, Bellinzona | OTHER |
| Kantonsspital Graubünden | OTHER |
| University Hospital, Geneva | OTHER |
| Centre Hospitalier Universitaire Vaudois | OTHER |
| Ostschweizer Kinderspital | OTHER |
| Kantonsspital Winterthur KSW | OTHER |
| Sanofi | INDUSTRY |
| Hôpital Fribourgeois | OTHER |
| University Children's Hospital, Zurich | OTHER |
| Luzerner Kantonsspital | OTHER |
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| Death date | Date of death | Life-long; Up to 80 years |
| Death cause | Cause of death | Life-long; Up to 80 years |
| Change in EDSS | EDSS change over time | Until reaching of adulthood (0 to 18 years) |
| Change in Neurostatus | Neurostatus change over time | Until reaching of adulthood (0 to 18 years) |
| Change in medication | Change of IBrainD medication over time | Until reaching of adulthood (0 to 18 years) |
| Change in Education | Evolution of education over time | Until reaching of adulthood (0 to 18 years) |
| Change in MRI data | Change in number of CNS lesions | Until reaching of adulthood (0 to 18 years) |
| Change in MRI data | Change in activity of CNS lesions | Until reaching of adulthood (0 to 18 years) |
| Change in laboratory test data | Change in diagnostic markers | Until reaching of adulthood (0 to 18 years) |
| Electrophysiological testing | Assessment if the patient did undergo electrophysiological testing. | Until reaching of adulthood (0 to 18 years) |
| Children's Hospital of Eastern Switzerland | Recruiting | Sankt Gallen | Canton of St. Gallen | 9000 | Switzerland |
|
| University Children's Hospital Lausanne (CHUV) | Recruiting | Lausanne | Canton of Vaud | 1011 | Switzerland |
|
| Kantonsspital Winterthur | Recruiting | Winterthur | Canton of Zurich | 8400 | Switzerland |
|
| Pediatric Institute of Southern Switzerland, Ospedale San Giovanni | Recruiting | Bellinzona | Canton Ticino | 6500 | Switzerland |
|
| Kantonsspital Graubünden | Recruiting | Chur | Kanton Graubünden | 7000 | Switzerland |
|
| University Children's Hospital Basel, UKBB | Recruiting | Basel | 4031 | Switzerland |
|
| University Children's Hospital, Inselspital Bern | Recruiting | Bern | 3010 | Switzerland |
|
| Institute of Social and Preventive Medicine, University of Bern | Recruiting | Bern | 3012 | Switzerland |
|
| Hôpital Fribourgeois - Freiburger Spital | Not yet recruiting | Fribourg | 1752 | Switzerland |
|
| University Hospitals of Geneva (HUG) | Recruiting | Geneva | 1211 | Switzerland |
|
| Kinderspital Zentralschweiz | Recruiting | Lucerne | 6000 | Switzerland |
|
| University Children's Hospital Zurich | Recruiting | Zurich | 8032 | Switzerland |
|
| ID | Term |
|---|---|
| D009902 | Optic Neuritis |
| D009188 | Myelitis, Transverse |
| D004673 | Encephalomyelitis, Acute Disseminated |
| D009103 | Multiple Sclerosis |
| D009471 | Neuromyelitis Optica |
| D060426 | Anti-N-Methyl-D-Aspartate Receptor Encephalitis |
| D020274 | Autoimmune Diseases of the Nervous System |
| D020293 | Vasculitis, Central Nervous System |
| D020945 | Lupus Vasculitis, Central Nervous System |
| D004660 | Encephalitis |
| D000098542 | Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease |
| ID | Term |
|---|---|
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010257 | Paraneoplastic Syndromes |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D002493 | Central Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D003711 | Demyelinating Diseases |
| D019636 | Neurodegenerative Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D056784 | Leukoencephalopathies |
| D001927 | Brain Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014657 | Vasculitis |
| D008590 | Meningoencephalitis |
| D020805 | Central Nervous System Viral Diseases |
| D008581 | Meningitis |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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