Biomarkers of Brain Injury in Children With Brain Tumors

Biomarkörer för hjärnskada Hos Barn Med hjärntumör

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07381959

Acronym

BiomarkCBT

Enrollment

560

Registered

2026-02-02

Start date

2021-08-01

Completion date

2031-12-31

Last updated

2026-02-02

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

Conditions

Brain Tumor, Childhood Brain Tumor, Childhood Cancer

Keywords

Radiotherapy, Cranial radiation therapy, Plasma biomarkers, Extracellular vesicles, Proteomics, Childhood brain tumor

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 17 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Sweden

Contacts

CONTACTChristoffer Ehrstedt, MD, PhD

christoffer.ehrstedt@uu.se0046-(0)18-611-0114

PRINCIPAL_INVESTIGATORArja Harila, MD, PhD

Uppsala University

Outcome results