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Cerebellar Mutism Syndrome Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02300766
Recruitment Status : Recruiting
First Posted : November 25, 2014
Last Update Posted : September 19, 2019
Sponsor:
Collaborators:
Odense University Hospital
Aarhus University Hospital
Aalborg University Hospital
Technical University of Denmark
Karolinska University Hospital
Skane University Hospital
University Hospital, Linkoeping
Uppsala University Hospital
Sahlgrenska University Hospital, Sweden
University Hospital, Umeå
Oslo University Hospital
Trondheim University Hospital
Haukeland University Hospital
University Hospital of North Norway
Helsinki University Central Hospital
Tampere University Hospital
Kuopio University Hospital
Turku University Hospital
Oulu University Hospital
Radboud University
Liverpool University Hospitals NHS Foundation Trust
Great Ormond Street Hospital for Children NHS Foundation Trust
Nottingham University Hospitals NHS Trust
University Hospital Birmingham
University Hospitals Bristol NHS Foundation Trust
Royal Infirmary of Edinburgh
South Glasgow University Hospitals NHS Trust
University Hospital Tuebingen
Information provided by (Responsible Party):
Jonathan Grønbæk, Rigshospitalet, Denmark

Brief Summary:
The purpose of this study is to determine why up to 25% of the pediatric patients who have surgery for a tumor in the posterior fossa develops the Cerebellar Mutism Syndrome (CMS). Furthermore the purpose is to explore the clinical course and the best treatment of the syndrome.

Condition or disease
Infratentorial Neoplasms Mutism

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Nordic Study of the Cerebellar Mutism Syndrome in Children With Brain Tumours of the Posterior Fossa
Study Start Date : October 2014
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2022

Group/Cohort
Posterior fossa tumor patients
Children (0-18 years) with a tumour in the posterior fossa (cerebellum/4th ventricle/brainstem ) requiring surgery or open biopsy at one of the participating centres.



Primary Outcome Measures :
  1. Development and progress of Cerebellar Mutism Syndrome [ Time Frame: 1 year after surgery ]
    The development of CMS is determined by a survey developed Robertson et al. The correlation between the risk of developing CMS and different neurosurgical techniques, genomic variants, treatments, tumor types, comorbidities, neuroradiologic findings, handedness and preoperative language status will be explored.


Secondary Outcome Measures :
  1. Development and progress of reduced speech output [ Time Frame: 1 year after surgery ]
    Speech production that is severely reduced and limited to single words or short sentences which can only be elicited after vigorous stimulation


Biospecimen Retention:   Samples With DNA
A blood sample from each patient will be collected in order to make SNP analyses on the DNA to explore the role of genomic variants on the development, severity and recovery from the CMS.


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All children (0-18 years) with a tumour in the posterior fossa (cerebellum/4th ventricle/brainstem ) requiring surgery or open biopsy at one of the participating centres.
Criteria

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

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): NCT02300766


Contacts
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Contact: Jonathan K Grønbæk, MD, PhD stud +45 27576367 jonathan.kjaer.groenbaek@regionh.dk
Contact: Astrid M Sehested, MD +45 35451367 astrid.marie.sehested@regionh.dk

Locations
Show Show 25 study locations
Sponsors and Collaborators
Rigshospitalet, Denmark
Odense University Hospital
Aarhus University Hospital
Aalborg University Hospital
Technical University of Denmark
Karolinska University Hospital
Skane University Hospital
University Hospital, Linkoeping
Uppsala University Hospital
Sahlgrenska University Hospital, Sweden
University Hospital, Umeå
Oslo University Hospital
Trondheim University Hospital
Haukeland University Hospital
University Hospital of North Norway
Helsinki University Central Hospital
Tampere University Hospital
Kuopio University Hospital
Turku University Hospital
Oulu University Hospital
Radboud University
Liverpool University Hospitals NHS Foundation Trust
Great Ormond Street Hospital for Children NHS Foundation Trust
Nottingham University Hospitals NHS Trust
University Hospital Birmingham
University Hospitals Bristol NHS Foundation Trust
Royal Infirmary of Edinburgh
South Glasgow University Hospitals NHS Trust
University Hospital Tuebingen
Investigators
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Study Chair: Kjeld Schmiegelow, MD, Dr. med Rigshospitalet, Denmark
Study Chair: Marianne Juhler, MD, Dr. med Rigshospitalet, Denmark
Study Chair: Karsten Nysom, MD Rigshospitalet, Denmark
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jonathan Grønbæk, MD, PhD student, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02300766    
Other Study ID Numbers: H-6-2014-002
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Keywords provided by Jonathan Grønbæk, Rigshospitalet, Denmark:
Cerebellar Mutism Syndrome
Posterior Fossa Tumor
Pediatric cancer
Neurosurgical techniques
Additional relevant MeSH terms:
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Infratentorial Neoplasms
Mutism
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases