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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 January 2024 |
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Main ID: |
NCT02300766 |
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Date of registration:
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21/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cerebellar Mutism Syndrome Study
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Scientific title:
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Nordic Study of the Cerebellar Mutism Syndrome in Children With Brain Tumours of the Posterior Fossa |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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1000 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02300766 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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Countries of recruitment
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Austria
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Belgium
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Czechia
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Denmark
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Finland
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Germany
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Hungary
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Italy
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Lithuania
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Netherlands
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Norway
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Sweden
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United Kingdom
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Contacts
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Name:
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Karsten Nysom, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rigshospitalet, Denmark |
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Name:
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Marianne Juhler, MD, Dr. med |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rigshospitalet, Denmark |
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Name:
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Aske F Laustsen, MD, PhD stud |
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Address:
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Telephone:
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+45 40218998 |
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Email:
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aske.foldbjerg.laustsen@regionh.dk |
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Affiliation:
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Name:
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Kjeld Schmiegelow, MD, Dr. med |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rigshospitalet, Denmark |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age < 18 years at the date of first imaging showing this tumour
- Tumour in the cerebellum/4th ventricle/brainstem with intention to treat with surgical
resection or open biopsy. Second and further surgeries are also included.
- Informed consent from custodial parent(s)
Exclusion Criteria:
- None
Age minimum:
N/A
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Mutism
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Infratentorial Neoplasms
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Primary Outcome(s)
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Development and progress of Cerebellar Mutism Syndrome
[Time Frame: 1 year after surgery]
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Secondary Outcome(s)
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Development and progress of reduced speech output
[Time Frame: 1 year after surgery]
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Secondary ID(s)
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H-6-2014-002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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