Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06417710

Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Leptomeningeal Metastasis Central Nervous System Neoplasms Leptomeningeal Cancer Leptomeningeal Disease Leptomeningeal Neoplasms Meningeal Carcinomatosis Meningeal Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Netherlands Cancer Institute, Amsterdam, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neurological assessment

Other

Clinical neurological assessment performed by 2 raters

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

  5. association of clinical response with imaging and CSF cytology response and the overall global clinical/MRI/CSF response

    Time frame: December 2026

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • M.D. Anderson Cancer Center
  • The Netherlands Cancer Institute

Registry information

Acronym: NANO-LM

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 16, 2024
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.