Blood biomarkers for treatment-related brain injury in children with brain tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational, longitudinal biomarker study enrolling children aged 0–17 with primary brain tumors and age- and sex-matched healthy controls. Researchers will collect plasma samples before surgery, shortly after surgery, at multiple follow-up points up to 36 months, and more frequently during any radiotherapy, to profile proteins and extracellular vesicles. Results from children treated with surgery, chemotherapy, and radiotherapy will be compared with radiation-naive patients and healthy controls to identify treatment-specific signals. The study uses proteomics and extracellular vesicle analyses to look for sensitive, minimally invasive markers of treatment-induced brain injury.

Why it matters

Who can join: the full rules

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.

Where it's running

• Uppsala University
  Uppsala, Sweden Recruiting

Study contacts

• Principal investigator: Arja Harila, MD, PhD — Uppsala University
• Study coordinator: Christoffer Ehrstedt, MD, PhD
• Email: christoffer.ehrstedt@uu.se
• Phone: 0046-(0)18-611-0114

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.