Biomarkers of Brain Injury in Children With Brain Tumors

NCT07381959 · tracked via the Priya Life Science Sweden tracker

Sponsor

Uppsala University

Phase

Observational

Started

2021-08-01

Last updated

2026-02-02

Condition(s) studied

Brain TumorChildhood CancerChildhood Brain Tumor

Study summary

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.

Eligibility

Sex

ALL

Min age

—

Max age

17 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Biomarker(s) of brain injury — 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)
Exploratory. "Brain injury" includes, e.g., changes visible on magnetic resonance imaging and neurocognitive follow-up assessments.

Trial sites (1)

Facility	City	Region	Status
Uppsala University	Uppsala	Sweden	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07381959 on ClinicalTrials.gov ↗ ← All trials in Sweden