Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Zurich

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Neurological Assessment

    Other intervention

    Clinical neurological assessment performed by 2 raters

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
December 2026

Secondary outcomes

1

inter-observer reproducibility (agreement) for each item - per center and among all raters

Time frame
December 2026
2

association between items

Time frame
December 2026
3

variability of the interobserver agreement

Time frame
December 2026
4

description of clinical neurological symptoms and signs

Time frame
December 2026

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Zurich

Lead sponsor

M.D. Anderson Cancer Center

Collaborator

The Netherlands Cancer Institute

Collaborator