Biomarkers of Brain Injury in Children With Brain Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Brain Tumor, Childhood Cancer, Childhood Brain Tumor. Basic parameters: up to 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Biomarkörer för hjärnskada Hos Barn Med hjärntumör
Overview
The goal of this observational study is to identify biomarkers of treatment-induced brain injury in children treated for primary brain tumors. The main question it aims to answer is: Can investigators identify sensitive plasma biomarker(s) of treatment-induced brain injury in children with primary brain tumors? Researchers will compare results between different treatment modalities (surgery, chemotherapy, radiation versus radiation-naive) and a healthy age- and sex-matched control population, to identify treatment-specific biomarkers. Participants will provide plasma samples at the following time points: before surgery, 1-2 weeks after surgery, as well as at 3-, 6-, 12-, 18-, 24-, and 36 months after surgery. Participants who receive radiation treatment will also provide plasma samples before and during treatment (approximately every 2 weeks). Where possible, plasma samples are also collected before the start of any new treatment (e.g., chemotherapy). Healthy controls will provide samples once.
Primary outcome measures
- Biomarker(s) of brain injury [Time frame: From enrollment until the end of study follow-up (up to 3 years after start of primary behandling for primary brain tumor, such as operation for brain tumor)]
Eligibility criteria
Inclusion Criteria, Group A (treated with radiation):
- Age 0-17 years old, AND
- Diagnosed with primary brain tumor through surgery, biopsy, or other diagnostic method (e.g., for germinoma) at Uppsala University Hospital or at another university hospital in Sweden, AND
- Referred for radiotherapy at Skandion Clinic in Uppsala and/or at their local hospital (in some cases), with/without the addition of other cancer treatments.
Inclusion Criteria, Group B (treated without radiation/radiation naive):
- Age 0-17 years old, AND
- Diagnosed with primary brain tumor through surgery, biopsy, or other diagnostic method (e.g., for optic pathway glioma in neurofibromatosis type 1 and germinoma) at Uppsala University Hospital or at another university hospital in Sweden, AND
- Not referred to radiotherapy and treated with/without the addition of other cancer treatments.
Inclusion Criteria, Group C (healthy control group):
- Age 0-17 years old at time of recruitment
Exclusion Criteria, Groups A + B:
- Diagnosed with a tumor only in the spinal cord (solitary spinal tumor).
- Diagnosed with a tumor considered palliative already at diagnosis (e.g., diffuse intrinsic pontine glioma)
Exclusion Criteria, Group C:
- Have diagnosis of chronic disease that requires continuous medication.
Exclusion Criteria, all groups:
- Unable to provide informed consent due to language difficulties.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Sweden · 1 center
- Uppsala University — Uppsala
Identifiers
NCT: NCT07381959 · LUL-964455