International Rare Brain Tumor Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,800
- 试验地点
- 16
- 主要终点
- Event-free Survival
研究概览
简要总结
The objective of the International Rare Brain Tumor Registry (IRBTR) is to better understand rare brain tumors through the collection of biospecimens and matched clinical data of children, adolescents, and young adult patients diagnosed with rare brain tumors.
详细描述
The International Rare Brain Tumor Registry (IRBTR) is a prospective observational study that will collect tumor samples and matched clinical and radiological data to better understand the outcomes of patients with rare brain tumors in particular: CNS sarcoma, BCOR, MN-1 altered tumors, PLAG/L1, and other rare or unclassified rare brain tumors.
Data collected include demographics, disease characteristics, treatment information, radiological imaging, and biospecimen collection if available ( tumor tissues Patients will be followed longitudinally to obtain outcome data. Data collection will continue for approximately 10 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a known or suspected CNS Sarcoma.
- •Patients with a known or suspected BCOR-altered brain tumor
- •Patients with a known or suspected Astroblastoma/NM-1 altered brain tumor
- •Patients with known or suspected histologically ambiguous/unclassifiable brain tumor
- •Patients with a known or suspected rare brain tumor.
- •Signed informed consent by patient/ parent or guardian (assent where applicable) to participate in the study.
排除标准
- •The patient has an extra-CNS primary tumor.
- •The patient is older than 46 years of age at diagnosis.
- •The patient or family is not willing to participate or does not sign informed consent.
研究组 & 干预措施
CNS Sarcoma
Patients diagnosed with Central nervous system (CNS) sarcomas
BCOR-altered
Patients diagnosed with tumors characterized by alterations in the BCOR gene.
Astroblastoma/MN-1- altered
Patients diagnosed with Astroblastomas/MN-1 alterations
Unclassifiable tumors
Patients diagnosed with histologically ambiguous tumors or tumors that fail to classify with the current diagnostic methods.
Other Rare Brain tumors
Patients diagnosed with other rare brain tumors that do not meet the criteria for cohorts 1-4.
结局指标
主要结局
Event-free Survival
时间窗: 10 years
The primary outcome measure will be time from diagnosis to an event, defined as the occurrence of progression or recurrence of the disease, occurrence of a second malignant neoplasm, or death from any cause. Each cohort will be analyzed separately.
次要结局
- Radiological characterization(10 years)
- Molecular characterization(10 years)
研究者
Adriana Fonseca
Oncologist
Children's National Research Institute