Brain TumorBiomarkCBTNCT07381959
Biomarkers of Brain Injury in Children With Brain Tumors
An observational study of Brain Tumor and Childhood Cancer, run by Uppsala University at 1 site in Sweden.
Trial 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?… Read more about this study
- Who is it for?
- Ages Up to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Tumor, Childhood Cancer, Childhood Brain Tumor
- How many people
- 560 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2021to 31 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- Healthy volunteers accepted
- Child
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).
Who may be able to join
- 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.
- Age 0-17 years old at time of recruitment
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University
Uppsala
Christoffer Ehrstedt, MD, PhD, christoffer.ehrstedt@uu.se
About this study
Official title: 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?
Read more
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
- Medical subject headings
- Brain Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Biomarker(s) of brain injury
Exploratory. "Brain injury" includes, e.g., changes visible on magnetic resonance imaging and neurocognitive follow-up assessments.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Aug 2021
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Blekinge, Dalarna County Council, Sweden, Region Gotland, Region Gävleborg, Region Uppsala Public Health and Care, Region Halland, Region Jämtland Härjedalen, Region Jönköping County, Region Kalmar län, Region Kronoberg, Region Norrbotten, Region Skane, Region Stockholm, Sormland County Council, Sweden, Region Värmland, Region Västerbotten, Region Västernorrland, Region Västmanland, Region Örebro län, Region Östergötland, Göteborg University, Västra Götalandsregionen
- Responsible party
- Sponsor
- Investigators
- Arja Harila, MD, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381959
- Sponsor's protocol ID
- LUL-964455
- Acronym
- BiomarkCBT
- Status last verified
- Jan 2026
- First submitted
- 29 Dec 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data can only be shared upon reasonable request, with appropriate approvals in place.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkörer för hjärnskada Hos Barn Med hjärntumör
- ClinicalTrials.gov ID
- NCT07381959
- Acronym / sponsor ID
- BiomarkCBT / LUL-964455
- Conditions
- Brain Tumor, Childhood Cancer, Childhood Brain Tumor
- Keywords
- Radiotherapy, Cranial radiation therapy, Plasma biomarkers, Extracellular vesicles, Proteomics, Childhood brain tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Region Blekinge, Dalarna County Council, Sweden, Region Gotland, Region Gävleborg, Region Uppsala Public Health and Care, Region Halland, Region Jämtland Härjedalen, Region Jönköping County, Region Kalmar län, Region Kronoberg, Region Norrbotten, Region Skane, Region Stockholm, Sormland County Council, Sweden, Region Värmland, Region Västerbotten, Region Västernorrland, Region Västmanland, Region Örebro län, Region Östergötland, Göteborg University, Västra Götalandsregionen
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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).
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: Undecided. Data can only be shared upon reasonable request, with appropriate approvals in place.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arja Harila, MD, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor and Childhood Cancer, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christoffer Ehrstedt, MD, PhD (0046-(0)18-611-0114, christoffer.ehrstedt@uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.