NCT07381959 Biomarkers of Brain Injury in Children With Brain Tumors
| NCT ID | NCT07381959 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Uppsala University |
| Condition | Brain Tumor |
| Study Type | OBSERVATIONAL |
| Enrollment | 560 participants |
| Start Date | 2021-08-01 |
| Primary Completion | 2031-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 560 participants in total. It began in 2021-08-01 with a primary completion date of 2031-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Arja Harila, MD, PhD
PRINCIPAL INVESTIGATOR
Uppsala University
Frequently Asked Questions
Who can join the NCT07381959 clinical trial?
This trial is open to participants of all sexes, up to 17 Years, studying Brain Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07381959 currently recruiting?
Yes, NCT07381959 is actively recruiting participants. Contact the research team at christoffer.ehrstedt@uu.se for enrollment information.
Where is the NCT07381959 trial being conducted?
This trial is being conducted at Uppsala, Sweden.
Who is sponsoring the NCT07381959 clinical trial?
NCT07381959 is sponsored by Uppsala University. The principal investigator is Arja Harila, MD, PhD at Uppsala University. The trial plans to enroll 560 participants.