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Research into clinical and MRI measures to get understanding of the neuropsychological outcome of children undergoing surgery for a brain tumor

FASTigial: Finding Anatomical SubsTrates of neuropsychological outcome in children with posterior fossa tumors (add-on project on the European CMS study)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN70465429
Enrollment
210
Registered
2024-05-28
Start date
2024-04-01
Completion date
Unknown
Last updated
2024-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly diagnosed pediatric brain tumors located in the posterior fossa Cancer

Interventions

For this multicenter observational study, patients participating in the study will be treated according to local standards. Additionally, we will conduct neuropsychological tests preoperatively, posto
NCT02300766).

Sponsors

Princess Máxima Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Eligible for European CMS study 1. Age 2-18 years at the date of first imaging showing this tumour 2. Understanding and speaking of local language by patient and/or parents Inclusion criteria European CMS study: 1. Age <18 years at the date of first imaging showing this tumour 2. Tumour in the cerebellum/4th ventricle/brainstem with the intention to treat with surgical resection or open biopsy.

Exclusion criteria

Exclusion criteria: 1. Patients who have had previous surgery on the posterior fossa 2. No informed consent from custodial parent(s) and/or patient

Design outcomes

Primary

MeasureTime frame
1. Age-standardized performance on executive functioning (neuropsychological domain) measured using questionnaires filled in by parents preoperatively, postoperatively, and 12 months after surgery. 2. White matter integrity and perfusion in the brain measured using MRI and clinical data (e.g., age, treatment) will be used to investigate early clinical and neuroradiological predictors of neuropsychological outcome preoperatively, postoperatively, and 12 months after surgery.

Secondary

MeasureTime frame
1. Age-standardized performance on neuropsychological measures, measured using computerized tests (Cogstate) and questionnaires preoperatively, postoperatively, and 12 months after surgery. 2. Clinical, neuroradiological (white matter integrity and perfusion) and neuropsychological variables will be collected to identify group differences and changes over time in posterior fossa tumor patients who have higher versus lower CMS symptom severity preoperatively, postoperatively, and 12 months after surgery.

Countries

Netherlands

Contacts

Public ContactMarita Partanen
M.H.Partanen@prinsesmaximacentrum.nl+31 889727272

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026