Biomarkers of Brain Injury in Children With Brain Tumors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 17
SponsorUppsala University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial 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).
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
560 Participants
are grouped into 3 trial groupsGroup A: Group A - Radiation
Group B: Group B - Radiation-naive
Group C: Group C - Healthy Controls
Trial outcomes
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.
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Uppsala University
Lead sponsor
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 Skane
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
Source ClinicalTrials.gov