About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Inability to give informed consent
Inability to adhere to recommended follow-up according to the treating physician
Trial population
Patients with leptomeningeal metastases from various extra-central nervous system (CNS) solid primary tumors for whom a tumor-specific treatment is planned
Trial design
Cohort
Prospective
Treatments tested in this trial
Neurological Assessment
Other interventionClinical neurological assessment performed by 2 raters
Treatment groups
Trial outcomes
Primary outcomes
inter-observer agreement of response assessment of the overall clinical assessment - per center and among all raters
Secondary outcomes
inter-observer reproducibility (agreement) for each item - per center and among all raters
association between items
variability of the interobserver agreement
description of clinical neurological symptoms and signs
Sponsors and contacts
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University of Zurich
Lead sponsor
M.D. Anderson Cancer Center
Collaborator
The Netherlands Cancer Institute
Collaborator