Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis

Recruiting

• Conditions: Leptomeningeal Disease; Leptomeningeal Neoplasms; Leptomeningeal Metastasis; Leptomeningeal Cancer

• Registration Number: NCT06417710
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-30
• Status Verified: 2024-05
• Study First Submitted: 2024-05-12
• Study First Submitted QC: 2024-05-12
• Last Update Submitted: 2024-05-12
• Study First Posted: 2024-05-16
• Last Update Posted: 2024-05-16
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
inter-observer agreement of response assessment of the overall clinical assessment - per center and among all raters	December 2026

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

University Hospital Zurich; 🇨🇭 Zurich, Switzerland

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Netherlands Cancer Institute; 🇳🇱 Amsterdam, Netherlands