Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis

NCT06417710 | Recruiting

• 1 other identifier: NANO-LM-01
• Study Type: observational
• Target: 200
• Locations: 3 countries
• Sites: 3

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.

Conditions

Leptomeningeal Metastasis; Leptomeningeal Disease; Leptomeningeal Neoplasms; Leptomeningeal Cancer

Outcome Measures

Primary Outcomes (1)

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

  December 2026

Secondary Outcomes (5)

• 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

Interventions

Neurological Assessment OTHER

Clinical neurological assessment performed by 2 raters

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Zurich: lead
• M.D. Anderson Cancer Center: collaborator
• The Netherlands Cancer Institute: collaborator

Study Sites (3)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Netherlands Cancer Institute

Amsterdam, Netherlands

RECRUITING

University Hospital Zurich

Zurich, Switzerland

RECRUITING

Related Publications (1)

• Le Rhun E, Nayak L, Lim-Fat MJ, Ruda R, Pentsova E, Forsyth P, O'Brien BJ, Preusser M, Kumthekar P, Brandsma D, Weller M. NANO-LM: An updated scorecard for the clinical assessment of patients with leptomeningeal metastases. Neuro Oncol. 2025 Feb 10;27(2):455-465. doi: 10.1093/neuonc/noae171.

  PMID: 39208403 DERIVED

MeSH Terms

Conditions

Meningeal Carcinomatosis; Meningeal Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2024
• First Posted: May 16, 2024
• Study Start: January 30, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

CH (1); NL (1); US (1)