NCT06417710招募中不适用
Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- inter-observer agreement of response assessment of the overall clinical assessment - per center and among all raters
研究概览
简要总结
The goal of this project is to develop and validate a reproducible scorecard for the neurological assessment of patients with leptomeningeal metastases that can be used in clinical trials including such patients, as well as in clinical practice.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (18 years or more), female or male
- •Histologically confirmed diagnosis of extra-CNS primary solid cancer
- •Diagnosis of leptomeningeal metastases confirmed or probable per EANO ESMO criteria
- •Performance status compatible with enrolment into clinical trials
- •Ability to consent
- •Signed informed consent form from patient
- •Participation in a parallel clinical trial is allowed in this non-interventional study
排除标准
- •Inability to give informed consent
- •Inability to adhere to recommended follow-up according to the treating physician
- •Vulnerable participants will not be included.
结局指标
主要结局
inter-observer agreement of response assessment of the overall clinical assessment - per center and among all raters
时间窗: December 2026
次要结局
- inter-observer reproducibility (agreement) for each item - per center and among all raters(December 2026)
- variability of the interobserver agreement(December 2026)
- association between items(December 2026)
- description of clinical neurological symptoms and signs(December 2026)
- association of clinical response with imaging and CSF cytology response and the overall global clinical/MRI/CSF response(December 2026)
研究者
研究点 (3)
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