Clinical trial · Observational
Biomarkers of Brain Injury in Children With Brain Tumors
Biomarkörer för hjärnskada Hos Barn Med hjärntumör
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Childhood Brain Tumor | Childhood Brain Neoplasm | ALIAS | 0.90 |
| Childhood Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Group A - Radiation
- description
- Children diagnosed with primary brain tumors who are treated with surgery and radiation therapy, and/or other cancer treatment (n=160).
- label
- Group B - Radiation-naive
- description
- Children diagnosed with primary brain tumors who are treated with surgery and/or other cancer treatment, but not radiation therapy (n=200).
- label
- Group C - Healthy Controls
- description
- Healthy children without brain tumors (n=200).
Primary outcomes (1)
- measure
- Biomarker(s) of brain injury
- timeFrame
- 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)
- description
- Exploratory. "Brain injury" includes, e.g., changes visible on magnetic resonance imaging and neurocognitive follow-up assessments.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 17 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available