Biomarkörer för hjärnskada Hos Barn Med hjärntumör
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 560
- 试验地点
- 1
- 主要终点
- Biomarker(s) of brain injury
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •, 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
排除标准
- •, 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.
研究组 & 干预措施
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).
结局指标
主要结局
Biomarker(s) of brain injury
时间窗: 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.
次要结局
未报告次要终点