Biomarkers of Brain Injury in Children With Brain Tumors (BiomarkCBT)

Uppsala University

Status: Enrolling

Conditions: Brain Tumor; Childhood Cancer; Childhood Brain Tumor

Study type: Observational

Funder types: Other

Identifiers

NCT07381959

LUL-964455

Details and patient eligibility

About

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.

Enrollment: 560 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

560 participants in 3 patient groups

Group A - Radiation

Description:

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

Description:

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

Description:

Healthy children without brain tumors (n=200).