Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis

University of Zurich3 sites in 3 countries200 target enrollmentJanuary 30, 2022

ConditionsLeptomeningeal Metastasis Leptomeningeal Disease Leptomeningeal Neoplasms Leptomeningeal Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Leptomeningeal Metastasis
Sponsor: University of Zurich
Enrollment: 200
Locations: 3
Primary Endpoint: inter-observer agreement of response assessment of the overall clinical assessment - per center and among all raters
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 30, 2022

End Date

December 2026

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

University of Zurich

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•Inability to give informed consent
•Inability to adhere to recommended follow-up according to the treating physician
•Vulnerable participants will not be included.

Outcomes

Primary Outcomes

inter-observer agreement of response assessment of the overall clinical assessment - per center and among all raters

Time Frame: December 2026

Secondary Outcomes

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)