NCT02300766

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.

Trial Health

88
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
13 countries

30 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Oct 2014Dec 2028

Study Start

First participant enrolled

October 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 25, 2014

Completed
14.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

14.3 years

First QC Date

November 21, 2014

Last Update Submit

September 24, 2025

Conditions

Infratentorial NeoplasmsMutism

Keywords

Cerebellar Mutism SyndromePosterior Fossa TumorPediatric cancerNeurosurgical techniques

Outcome Measures

Primary Outcomes (1)

  • Development and progress of Cerebellar Mutism Syndrome

    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.

    1 year after surgery

Secondary Outcomes (1)

  • Development and progress of reduced speech output

    1 year after surgery

Study Arms (1)

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.

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Medical University of Vienna

Vienna, Austria

RECRUITING

University Hospital Leuven

Leuven, Belgium

RECRUITING

Motol University Hospital

Prague, Czechia

RECRUITING

Aalborg University Hospital

Aalborg, 9100, Denmark

RECRUITING

Aarhus University Hospital

Aarhus, 8000, Denmark

RECRUITING

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Odense University Hospital

Odense, 5000, Denmark

RECRUITING

Helsinki University Central Hospital

Helsinki, Finland

RECRUITING

Kuopio University Hospital

Kuopio, Finland

NOT YET RECRUITING

Oulu University Hospital

Oulu, Finland

NOT YET RECRUITING

Tampere University Hospital

Tampere, Finland

NOT YET RECRUITING

Turku University Hospital

Turku, Finland

NOT YET RECRUITING

University of Leipzig Medical Center

Leipzig, Germany

RECRUITING

Semmelweis University, 2nd Dept of Pediatrics

Budapest, Hungary

RECRUITING

Ospedale Pediatrico Bambino Gesù

Rome, 00165, Italy

RECRUITING

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, Lithuania

RECRUITING

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6525, Netherlands

RECRUITING

UMC Groningen

Groningen, Netherlands

ACTIVE NOT RECRUITING

UMC Utrecht

Utrecht, Netherlands

RECRUITING

Haukeland University Hospital

Bergen, Norway

RECRUITING

Oslo University Hospital

Oslo, Norway

NOT YET RECRUITING

University Hospital of North Norway

Tromsø, Norway

NOT YET RECRUITING

St. Olav's Hospital

Trondheim, Norway

RECRUITING

Sahlgrenska University Hospital

Gothenburg, Sweden

RECRUITING

Linköping University Hospital

Linköping, Sweden

RECRUITING

Skåne University Hospital

Skåne, Sweden

RECRUITING

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

University Hospital of Umeå

Umeå, Sweden

RECRUITING

Uppsala University Hospital

Uppsala, Sweden

RECRUITING

Alder Hey Childrens NHS Foundation Trust

Liverpool, United Kingdom

RECRUITING

Related Publications (5)

  • Laustsen AF, Fric R, Gronbaek JK, Benes V, Lopez VS, Nestler U, Carai A, Solanki G, Avula S, Malluci C, Nilsson P, Nyman P, Hjort MA, Brandsma R, Hoving E, Bua A, Taborska J, Mudra K, Balazs M, Rutkaiskiene G, Rocka S, Lemiere J, Wilhelmy F, Dorfer C, Sehested A, Juhler M, Mathiasen R. Preoperative hydrocephalus and the risk of postoperative speech impairment following posterior fossa tumour surgery in children: results from a prospective, multinational cohort study. Childs Nerv Syst. 2026 Feb 4;42(1):60. doi: 10.1007/s00381-026-07132-z.

    PMID: 41639295DERIVED

  • Laustsen AF, Gronbaek JK, Fric R, Avula S, Mallucci C, Nilsson P, Nyman P, Hauser P, Mudra K, Kiudeliene R, Rocka S, Hjort MA, Brandsma R, Hoving E, Carai A, Benes V, Taborska J, Dorfer C, Jacobs S, Pavon-Mengual M, Skjoth-Rasmussen J, Schmiegelow K, Sehested A, Mathiasen R, Juhler M. Postoperative speech impairment and cranial nerve deficits in children undergoing posterior fossa tumor surgery with intraoperative MRI - a prospective multinational study. Acta Neurochir (Wien). 2025 Sep 22;167(1):252. doi: 10.1007/s00701-025-06669-3.

    PMID: 40982141DERIVED

  • Sarup R, Laustsen AF, Sorensen MK, Mallucci C, Pizer B, Aquilina K, Molinari E, Hjort MA, Fric R, Nyman P, Sabel M, Nilsson P, Matukevicius A, Hauser P, Mudra K, Carai A, Zipfel J, Hoving E, van Baarsen K, IIIrd VB, Peyrl A, Nysom K, Sehested AM, Schmiegelow K, Juhler M, Gronbaek JK, Mathiesen R. Glucocorticoid use in paediatric posterior fossa tumour surgery and the occurrence of postoperative speech impairment. Childs Nerv Syst. 2025 Jul 11;41(1):231. doi: 10.1007/s00381-025-06850-0.

    PMID: 40643729DERIVED

  • Laustsen AF, Avula S, Gronbaek J, Pizer B, Nyman P, Nilsson P, Fric R, Hjort MA, Benes V, Hauser P, Palmafy B, Rutkauskiene G, Wilhelmy F, Brandsma R, Sehested A, Mathiasen R, Juhler M. Tumour volume as a predictor of postoperative speech impairment in children undergoing resection of posterior fossa tumours: a prospective, multicentre study. Acta Neurochir (Wien). 2025 Apr 3;167(1):97. doi: 10.1007/s00701-025-06459-x.

    PMID: 40178678DERIVED

  • Wibroe M, Cappelen J, Castor C, Clausen N, Grillner P, Gudrunardottir T, Gupta R, Gustavsson B, Heyman M, Holm S, Karppinen A, Klausen C, Lonnqvist T, Mathiasen R, Nilsson P, Nysom K, Persson K, Rask O, Schmiegelow K, Sehested A, Thomassen H, Tonning-Olsson I, Zetterqvist B, Juhler M. Cerebellar mutism syndrome in children with brain tumours of the posterior fossa. BMC Cancer. 2017 Jun 21;17(1):439. doi: 10.1186/s12885-017-3416-0.

    PMID: 28637445DERIVED

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.

MeSH Terms

Conditions

Infratentorial NeoplasmsMutismNeoplasms

Condition Hierarchy (Ancestors)

Brain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Kjeld Schmiegelow, MD, Dr. med

    Rigshospitalet, Denmark

    STUDY CHAIR

  • Marianne Juhler, MD, Dr. med

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

  • Karsten Nysom, MD

    Rigshospitalet, Denmark

    STUDY CHAIR

Central Study Contacts

Aske F Laustsen, MD, PhD stud

CONTACT

+45 40218998aske.foldbjerg.laustsen@regionh.dk

Astrid M Sehested, MD

CONTACT

+45 35451367astrid.marie.sehested@regionh.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD student

Study Record Dates

First Submitted

November 21, 2014

First Posted

November 25, 2014

Study Start

October 1, 2014

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

September 26, 2025

Record last verified: 2025-09

Locations

NO(4)AU(1)DE(1)HU(1)DK(4)BE(1)LI(1)NL(3)GB(1)CZ(1)FI(5)IT(1)SE(6)