Biomarkers of Brain Injury in Children With Brain Tumors
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Brain Tumor, Childhood Cancer, Childhood Brain Tumor. Базовые параметры: до 17 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Швеция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Biomarkörer för hjärnskada Hos Barn Med hjärntumör
Обзор
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.
Первичные конечные точки
- Biomarker(s) of brain injury [Срок оценки: 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)]
Критерии участия
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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Случай-контроль
Центры проведения
Швеция · 1 центр
- Uppsala University — Uppsala
Идентификаторы
NCT: NCT07381959 · LUL-964455