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Cerebellar Mutism Syndrome Study

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ClinicalTrials.gov Identifier: NCT02300766
Recruitment Status : Recruiting
First Posted : November 25, 2014
Last Update Posted : December 21, 2017
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
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

  Show Detailed Description

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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
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Denmark
Aalborg University Hospital Recruiting
Aalborg, Denmark, 9100
Contact: Steen Rosthøj, MD       steen.rosthoej@rn.dk   
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Niels Clausen, MD    +45 78451700    nc@dadlnet.dk   
Contact: Karen O Møller, Nurse    +45 78451719    karemoel@rm.dk   
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Jonathan K Grønbæk, MD, PhD stud    +45 27576367    jonathan.kjaer.groenbaek@regionh.dk   
Contact: Marianne Juhler, MD, Dr. med    +45 35452088    marianne.juhler@gmail.com   
Sub-Investigator: Astrid Sehested, MD         
Sub-Investigator: Morten A Wibroe, MD, PhD         
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Peder S Wehner, MD    +45 6541 2086    peder.skov.wehner@ouh.regionsyddanmark.dk   
Finland
Helsinki University Central Hospital Recruiting
Helsinki, Finland
Contact: Tuula Lönnqvist       tuula.lonnqvist@hus.fi   
Contact: Atte Karppinen       Atte.Karppinen@hus.fi   
Kuopio University Hospital Not yet recruiting
Kuopio, Finland
Contact: Jouni Pesola       jouni.pesola@kuh.fi   
Oulu University Hospital Not yet recruiting
Oulu, Finland
Contact: Satu Lehtinen       satu.lehtinen@ppshp.fi   
Tampere University Hospital Not yet recruiting
Tampere, Finland
Contact: Kristiina Nordfors       kristiina.nordfors@gmail.com   
Turku University Hospital Not yet recruiting
Turku, Finland
Contact: Päivi Lähteenmäki       paivi.maria.lahteenmaki@tyks.fi   
Contact: Marika Gronroos       marika.gronroos@tyks.fi   
Hungary
Semmelweis University, 2nd Dept of Pediatrics Recruiting
Budapest, Hungary
Contact: Péter Hauser, MD, PhD       hauserpeti@yahoo.com   
Lithuania
Hospital of Lithuanian University of Health Sciences Kauno klinikos Recruiting
Kaunas, Lithuania
Contact: Rosita Kiudeline       rosikiud@gmail.com   
Contact: Giedre Rutkauskiene       giedre.rutkauskiene@gmail.com   
Netherlands
Radboud University Nijmegen Medical Centre Recruiting
Nijmegen, Gelderland, Netherlands, 6525
Contact: Leonie v d Abbeele       Leonie.vandenAbbeele@radboudumc.nl   
UMC Groningen Active, not recruiting
Groningen, Netherlands
UMC Utrecht Recruiting
Utrecht, Netherlands
Contact: Kirsten van Barsen       K.M.vanBaarsen-2@umcutrecht.nl   
Norway
Haukeland University Hospital Recruiting
Bergen, Norway
Contact: Ingrid K Torsvik       ingrid.kristin.torsvik@helse-bergen.no   
Oslo University Hospital Not yet recruiting
Oslo, Norway
Contact: Einar Stensvold         
University Hospital of North Norway Not yet recruiting
Tromsø, Norway
Contact: Tore Stokland       tore.stokland@unn.no   
St. Olav's Hospital Recruiting
Trondheim, Norway
Contact: Harald Thomassen       harald.thomassen@stolav.no   
Contact: Johan Cappelen       johan.cappelen@stolav.no   
Sweden
Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden
Contact: Magnus Sabel       magnus.sabel@vgregion.se   
Linköping University Hospital Recruiting
Linköping, Sweden
Contact: Irene Devenney       Irene.Devenney@lio.se   
Skåne University Hospital Recruiting
Skåne, Sweden
Contact: Charlotte Castor       charlotte.castor@med.lu.se   
Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Pernilla Grillner    +46 08-524 879 55    Pernilla.Grillner@ki.se   
University Hospital of Umeå Recruiting
Umeå, Sweden
Contact: Mattias Mattsson       mattias.mattsson@vll.se   
Uppsala University Hospital Recruiting
Uppsala, Sweden
Contact: Christoffer Ehrstedt       christoffer.ehrstedt@akademiska.se   
Contact: Pelle Nilsson       pelle.nilsson@akademiska.se   
United Kingdom
Alder Hey Childrens NHS Foundation Trust Recruiting
Liverpool, United Kingdom
Contact: Conor Mallucci       conor.mallucci@alderhey.nhs.uk   
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
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     History of Changes
Other Study ID Numbers: H-6-2014-002
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017

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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Speech Disorders
Mutism
Infratentorial Neoplasms
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