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Swiss Pediatric Inflammatory Brain Disease Registry (Swiss-Ped-IBrainD)

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ClinicalTrials.gov Identifier: NCT05017142
Recruitment Status : Recruiting
First Posted : August 23, 2021
Last Update Posted : August 23, 2021
Sponsor:
Collaborators:
Schweizerische Multiple Sklerose Gesellschaft
University Hospital Inselspital, Berne
Roche Pharma (Switzerland) Ltd
Novartis
Information provided by (Responsible Party):
University of Bern

Brief Summary:
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 were opened for recruitment in 2021; Aarau, Basel, Bellinzona, Chur, Geneva, Lausanne, Lucerne, St. Gallen, and Zurich. The center in Winterthur is expected to be open for recruitment by autumn 2021. 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.

Condition or disease
Optic Neuritis Transverse Myelitis Acute Disseminated Encephalomyelitis Multiple Sclerosis Neuromyelitis Optica Spectrum Disorder Anti-NMDAR Encephalitis Anti-GAD65 Associated Autoimmune Encephalitis Anti-AMPAR-1/2 Associated Autoimmune Encephalitis Anti-Lgi-1 Associated Autoimmune Encephalitis Anti-CASPR-2 Associated Autoimmune Encephalitis Anti-GABAR-1/2 Associated Autoimmune Encephalitis Onconeuronal Antibody (Hu, Ri, Yo, Amphiphysin, CRMP-5, Ma-1, Ma-2, SOX-1) Associated Autoimmune Encephalitis Hashimoto Encephalitis CNS Vasculitis CNS Sarcoidosis CNS Lupus Rasmussen Encephalitis

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 18 Years
Official Title: Swiss Pediatric Inflammatory Bain Disease Cohort Study
Actual Study Start Date : April 14, 2020
Estimated Primary Completion Date : January 1, 2071
Estimated Study Completion Date : January 1, 2071


Group/Cohort
Patient population
Children, adolescents and adults diagnosed with an IBrainD before age 18, who are born, treated or living in Switzerland



Primary Outcome Measures :
  1. Personal data [ Time Frame: At registration (Life-long; Up to 80 years) ]
    Registering patient's personal data

  2. Diagnosis [ Time Frame: Until reaching of adulthood (0 to 18 years) ]
    Diagnosis of IBrainD

  3. Age at diagnosis [ Time Frame: Until reaching of adulthood (0 to 18 years) ]
    Age at diagnosis (months and years)

  4. First symptoms [ Time Frame: Until reaching of adulthood (0 to 18 years) ]
    Symptoms before diagnosis

  5. Age at first symptoms [ Time Frame: Until reaching of adulthood (0 to 18 years) ]
    Age at first symptoms

  6. Diagnostic delay [ Time Frame: Until reaching of adulthood (0 to 18 years) ]
    Time elapsed between symptom-onset and diagnosis (days)

  7. Hospitalization [ Time Frame: Until reaching of adulthood (0 to 18 years) ]
    Length of hospitalization at diagnosis or during a relapse (days)

  8. Rehabilitation [ Time Frame: Until reaching of adulthood (0 to 18 years) ]
    Length and type of rehabilitation at diagnosis or during a relapse (days)

  9. Death date [ Time Frame: Life-long; Up to 80 years ]
    Date of death

  10. Death cause [ Time Frame: Life-long; Up to 80 years ]
    Cause of death

  11. Change in EDSS [ Time Frame: Until reaching of adulthood (0 to 18 years) ]
    EDSS change over time

  12. Change in Neurostatus [ Time Frame: Until reaching of adulthood (0 to 18 years) ]
    Neurostatus change over time

  13. Change in medication [ Time Frame: Until reaching of adulthood (0 to 18 years) ]
    Change of IBrainD medication over time

  14. Change in Education [ Time Frame: Until reaching of adulthood (0 to 18 years) ]
    Evolution of education over time

  15. Change in MRI data [ Time Frame: Until reaching of adulthood (0 to 18 years) ]
    Change in number of CNS lesions

  16. Change in MRI data [ Time Frame: Until reaching of adulthood (0 to 18 years) ]
    Change in activity of CNS lesions

  17. Change in laboratory test data [ Time Frame: Until reaching of adulthood (0 to 18 years) ]
    Change in diagnostic markers

  18. Electrophysiological testing [ Time Frame: Until reaching of adulthood (0 to 18 years) ]
    Assessment if the patient did undergo electrophysiological testing.


Secondary Outcome Measures :
  1. Future questionnaires [ Time Frame: Life-long; Up to 80 years; Will mainly concern childhood (until reaching of adulthood; 0 to 18 years) ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients living and/or treated in Switzerland with a listed IBrainD and a disease onset before the age of 18.
Criteria

Inclusion Criteria:

All patients living and/or treated in Switzerland with an IBrainD specified in the following list with a disease onset before the age of 18.

  • Written informed consent by patients (and/or legal representative(s), if applicable)
  • Optic Neuritis
  • Transverse Myelitis
  • Acute disseminated encephalomyelitis
  • Multiple Sclerosis
  • Neuromyelitis Optica Spectrum Disorders
  • Anti-NMDA-R Encephalitis
  • Anti-GAD65 Associated Autoimmune Encephalitis
  • Anti-AMPAR-1/2 Associated Autoimmune Encephalitis
  • Anti-Lgi-1 Associated Autoimmune Encephalitis
  • Anti-CASPR-2 Associated Autoimmune Encephalitis
  • Anti-GABAR-1/2 Associated Autoimmune Encephalitis
  • Onconeuronal Antibody (Hu, Ri, Yo, Amphiphysin, CRMP-5, Ma-1, Ma-2, SOX-1) Associated Autoimmune Encephalitis
  • Hashimoto Encephalopathy
  • CNS Vasculitis
  • CNS Sarcoidosis
  • CNS Lupus
  • Rasmussen Encephalitis

Exclusion Criteria:

  • Neurological symptoms due to infectious diseases of the CNS
  • Genetic/metabolic causes of central demyelinating diseases
  • Neurological symptoms due to Guillain-Barré-Syndrome

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05017142


Contacts
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Contact: Lorena F Hulliger, MSc 0316845678 ext +41 lorena.hulliger@ispm.unibe.ch

Locations
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Switzerland
Kantonsspital Aarau Recruiting
Aarau, Aargau, Switzerland, 5001
Contact: Andrea Capone Mori         
Kantonsspital Graubünden Recruiting
Chur, Graubünden, Switzerland, 7000
Contact: Susi Strozzi         
Children's Hospital of Eastern Switzerland Recruiting
St.Gallen, Saint Gallen, Switzerland, 9000
Contact: Oliver Maier         
Contact: Tanja Wachinger         
Pediatric Institute of Southern Switzerland, Ospedale San Giovanni Recruiting
Bellinzona, Ticino, Switzerland, 6500
Contact: Barbara Goeggel Simonetti         
University Children's Hospital Lausanne (CHUV) Not yet recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Judith Kalser         
Kinderspital Winterthur Not yet recruiting
Winterthur, Zurich, Switzerland, 8400
Contact: Regula Schmid         
University Children's Hospital Basel, UKBB Recruiting
Basel, Switzerland, 4031
Contact: Patricia Dill         
University Children's Hospital, Inselspital Bern Recruiting
Bern, Switzerland, 3010
Contact: Sandra Bigi         
Institute of Social and Preventive Medicine, University of Bern Recruiting
Bern, Switzerland, 3012
Contact: Lorena F Hulliger         
Contact: Claudia E Kuehni         
University Hospitals of Geneva (HUG) Not yet recruiting
Geneva, Switzerland, 1211
Contact: Stéphanie Garcia-Tarodo         
Luzerner Kantonsspital Recruiting
Luzern, Switzerland, 6000
Contact: Florian Bauder         
University Children's Hospital Zurich Recruiting
Zurich, Switzerland, 8032
Contact: Annette Hackenberg         
Sponsors and Collaborators
University of Bern
Schweizerische Multiple Sklerose Gesellschaft
University Hospital Inselspital, Berne
Roche Pharma (Switzerland) Ltd
Novartis
Investigators
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Principal Investigator: Sandra Bigi, PD MD ISPM, University of Bern, Bern; University Children's Hospital, University of Bern, Bern
Study Director: Sandra Bigi, PD MD ISPM, University of Bern, Bern; University Children's Hospital, University of Bern, Bern
Study Director: Claudia E Kuehni, Prof. MD ISPM, University of Bern, Bern
Additional Information:
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Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT05017142    
Other Study ID Numbers: 2019-00377
First Posted: August 23, 2021    Key Record Dates
Last Update Posted: August 23, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Encephalomyelitis
Myelitis
Myelitis, Transverse
Anti-N-Methyl-D-Aspartate Receptor Encephalitis
Multiple Sclerosis
Encephalitis
Neuritis
Optic Neuritis
Neuromyelitis Optica
Vasculitis, Central Nervous System
Encephalomyelitis, Acute Disseminated
Vasculitis
Sarcoidosis
Hashimoto Disease
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Optic Nerve Diseases
Cranial Nerve Diseases