BRIANSTORM - Early Identification of Patients With Brain Metastases
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of brain metastasis
研究概览
简要总结
A single arm observational study investigating the incidence of brain metastasis in patients with cancer recti and lung metastasis
详细描述
In this study the investigators want to investigate the incidence of brain metastasis in a selected high-risk group of patients with metastatic colorectal cancer. Possible prognostic biological aspects will be investigated by translational analysis of biological samples. The study population consists of patients with metastatic rectal cancer and presence of lung metastasis. The patients will undergo a standard MRI scan of the brain including injection of intravenous contrast. If positive finding, images will be evaluated at the multidisciplinary tumor board for potential treatment options according to clinical practice. Standard follow-up program is followed, as per clinical practice. If the initial MRI scan of cerebrum detects brain metastasis this will be treated and followed as per clinical practice. Translational blood samples will be drawn at inclusion and at every imaging schedule up til 5 times
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary rectal tumor location
- •Diagnosis of lung metastasis made by histo- or cytopathology, or by clinical and imaging criteria.
- •Able to understand written information
- •Consent to samples for translational research
排除标准
- •Contraindications for MRI Priorly treated or known brain metastases
结局指标
主要结局
Incidence of brain metastasis
时间窗: 2 years
Incidence of brain metastasis in a high risk selected group
次要结局
- Number of brain metastases eligible for local treatment options(2 years)
- Prognostic value of circulating DNA levels at baseline(2 years last patient)
- Descriptive biological analysis of tumor tissue and circulating tumor DNA(2 years last patient)
- Median two year overall survival(2 years last patient)
研究者
Anders Kindberg Boysen
MD, PhD
Aarhus University Hospital