Understanding Cerebellar Mutism Syndrome in Pediatric Brain Tumor Patients
Nordic Study of the Cerebellar Mutism Syndrome in Children With Brain Tumours of the Posterior Fossa
This study looks at why some kids who have surgery for brain tumors develop Cerebellar Mutism Syndrome and aims to find better ways to help them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 30 sites (Vienna and 29 other locations) |
| Trial ID | NCT02300766 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate why up to 25% of pediatric patients who undergo surgery for posterior fossa tumors develop Cerebellar Mutism Syndrome (CMS). It will explore the clinical course, risk factors, and potential treatments for CMS by collecting clinical data and imaging from a minimum of 500 patients across multiple centers in the Nordic countries. The study began in 2014 and includes genetic analysis through blood samples to further understand the syndrome's etiology. The findings could lead to improved management strategies for affected children.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients under 18 years old with tumors located in the cerebellum, fourth ventricle, or brainstem who are undergoing surgical treatment.
Not a fit: Patients with tumors outside the specified brain regions or those over 18 years old will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and treatment options for children suffering from Cerebellar Mutism Syndrome.
How similar studies have performed: While similar studies have explored pediatric brain tumors, the specific focus on Cerebellar Mutism Syndrome in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vienna and 29 other locations
- Medical University of Vienna — Vienna, Austria (Recruiting)
- University Hospital Leuven — Leuven, Belgium (Recruiting)
- Motol University Hospital — Prague, Czechia (Recruiting)
- Aalborg University Hospital — Aalborg, Denmark (Recruiting)
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
- Odense University Hospital — Odense, 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, Italy (Recruiting)
- Hospital of Lithuanian University of Health Sciences Kauno klinikos — Kaunas, Lithuania (Recruiting)
- Radboud University Nijmegen Medical Centre — Nijmegen, Gelderland, 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)
Study contacts
- Principal investigator: Marianne Juhler, MD, Dr. med — Rigshospitalet, Denmark
- Study coordinator: Aske F Laustsen, MD, PhD stud
- Email: aske.foldbjerg.laustsen@regionh.dk
- Phone: +45 40218998
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.