Biomarkers of Brain Injury in Children With Brain Tumors (BiomarkCBT)

January 28, 2026 updated by: Uppsala University

Biomarkörer för hjärnskada Hos Barn Med hjärntumör

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

560

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Groups A and B will be selected from all children, 0-17 years of age, in Sweden with primary (newly diagnosed) brain tumors.

Group C will be selected from:

  • Healthy sibling controls to other study participants, OR
  • Siblings to other children admitted to Uppsala University Hospital, OR
  • Other healthy children for example those who attend Uppsala University Hospital for another reason (e.g., minor elective daycare surgery).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group A - Radiation
Children diagnosed with primary brain tumors who are treated with surgery and radiation therapy, and/or other cancer treatment (n=160).
Group B - Radiation-naive
Children diagnosed with primary brain tumors who are treated with surgery and/or other cancer treatment, but not radiation therapy (n=200).
Group C - Healthy Controls
Healthy children without brain tumors (n=200).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

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

Investigators

  • Principal Investigator: Arja Harila, MD, PhD, Uppsala University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

December 31, 2031

Study Registration Dates

First Submitted

December 29, 2025

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUL-964455

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data can only be shared upon reasonable request, with appropriate approvals in place.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Brain Tumor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe