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NCT Number: NCT07381959

Biomarkers of Brain Injury in Children With Brain Tumors

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.

Recruiting

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Key information

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uppsala University

Uppsala, Sweden

Location status: Recruiting

Location contact

Christoffer Ehrstedt, MD, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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)

    Exploratory. "Brain injury" includes, e.g., changes visible on magnetic resonance imaging and neurocognitive follow-up assessments.

Study contacts

Contact information is provided by the study sponsor or research team.

Christoffer Ehrstedt, MD, PhD

CONTACT

[email protected]

0046-(0)18-611-0114

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Göteborg University
  • Region Blekinge
  • Region Dalarna
  • Region Gotland
  • Region Gävleborg
  • Region Halland
  • Region Jämtland Härjedalen
  • Region Jönköping County
  • Region Kalmar län
  • Region Kronoberg
  • Region Norrbotten
  • Region Skane
  • Region Stockholm
  • Region Uppsala
  • Region Värmland
  • Region Västerbotten
  • Region Västernorrland
  • Region Västmanland
  • Region Örebro län
  • Region Östergotland
  • Sormland County Council, Sweden
  • Västra Götalandsregionen

Registry information

Official study title

Biomarkörer för hjärnskada Hos Barn Med hjärntumör

Acronym: BiomarkCBT

Important dates

Study start
2021
Primary completion
2031
Study completion
2031
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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