Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis (NANO-LM)

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.

Study Overview

• Status: Recruiting
• Conditions: Leptomeningeal Disease; Leptomeningeal Metastasis; Leptomeningeal Neoplasms; Leptomeningeal Cancer
• Intervention / Treatment: Other: Neurological Assessment

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • Netherlands Cancer Institute
    • Contact: Dieta Bransdma; Phone Number: +31 (0)20 512 9111; Email: d.brandsma@nki.nl
• Switzerland
  • Zurich, Switzerland
    • Recruiting
    • University Hospital Zurich
    • Contact: Emilie Le Rhun; Phone Number: +41 44 255 38 99; Email: emilie.lerhun@usz.ch
• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center
      • Contact: Barbara O'Brien; Phone Number: 832-837-9347; Email: BJOBrien@mdanderson.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with leptomeningeal metastases from various extra-central nervous system (CNS) solid primary tumors for whom a tumor-specific treatment is planned

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
inter-observer agreement of response assessment of the overall clinical assessment - per center and among all raters	December 2026

Secondary Outcome Measures

Outcome Measure	Time Frame
inter-observer reproducibility (agreement) for each item - per center and among all raters	December 2026
association between items	December 2026
variability of the interobserver agreement	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

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: M.D. Anderson Cancer Center; The Netherlands Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 12, 2024
• First Submitted That Met QC Criteria: May 12, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 12, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasm Metastasis; Meningeal Carcinomatosis; Meningeal Neoplasms
• Other Study ID Numbers: NANO-LM-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No