跳至主要内容
临床试验/NCT06417710
NCT06417710招募中不适用

Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis

University of Zurich3 个研究点 分布在 3 个国家目标入组 200 人开始时间: 2022年1月30日最近更新:
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

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

申办方类型
Other
责任方
Sponsor

研究点 (3)

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