Biomarkers of Brain Injury in Children With Brain Tumors

NCT07381959 | Recruiting

• 1 other identifier: LUL-964455
• Study Type: observational
• Target: 560
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumor; Childhood Cancer; Childhood Brain Tumor

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Biomarker(s) of brain injury

  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)

Study Arms (3)

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).

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• 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.
• 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.
• Age 0-17 years old at time of recruitment

You may not qualify if:

• 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)
• Have diagnosis of chronic disease that requires continuous medication.
• Unable to provide informed consent due to language difficulties.

Sponsors & Collaborators

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

Study Sites (1)

Uppsala University

Uppsala, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Ethylenediaminetetraacetic acid (EDTA)- and sodium citrate collection tubes will be used to collect plasma samples.

MeSH Terms

Conditions

Brain Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Arja Harila, MD, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoffer Ehrstedt, MD, PhD

CONTACT

0046-(0)18-611-0114; christoffer.ehrstedt@uu.se

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: February 2, 2026
• Study Start: August 1, 2021
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

SE (1)