Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Region Blekinge | UNKNOWN |
| Region Dalarna | UNKNOWN |
| Region Gotland | UNKNOWN |
| Region Gävleborg |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Not provided
Inclusion Criteria, Group A (treated with radiation):
Inclusion Criteria, Group B (treated without radiation/radiation naive):
Inclusion Criteria, Group C (healthy control group):
Exclusion Criteria, Groups A + B:
Exclusion Criteria, Group C:
Exclusion Criteria, all groups:
Not provided
Not provided
Not provided
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:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christoffer Ehrstedt, MD, PhD | Contact | 0046-(0)18-611-0114 | christoffer.ehrstedt@uu.se |
| Name | Affiliation | Role |
|---|---|---|
| Arja Harila, MD, PhD | Uppsala University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uppsala University | Recruiting | Uppsala | Sweden |
Data can only be shared upon reasonable request, with appropriate approvals in place.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
Not provided
Not provided
| Region Uppsala | UNKNOWN |
| Region Halland | OTHER |
| Region Jämtland Härjedalen | OTHER |
| Region Jönköping County | OTHER_GOV |
| Region Kalmar län | UNKNOWN |
| Region Kronoberg | UNKNOWN |
| Region Norrbotten | OTHER |
| Region Skane | OTHER |
| Region Stockholm | OTHER_GOV |
| Sormland County Council, Sweden | OTHER |
| Region Värmland | UNKNOWN |
| Region Västerbotten | OTHER_GOV |
| Region Västernorrland | UNKNOWN |
| Region Västmanland | OTHER |
| Region Örebro län | UNKNOWN |
| Region Östergotland | UNKNOWN |
| Göteborg University | OTHER |
| Västra Götalandsregionen | OTHER |
Not provided
Not provided
Not provided
Ethylenediaminetetraacetic acid (EDTA)- and sodium citrate collection tubes will be used to collect plasma samples.
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |