Recruiting NCT06417710
Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neurological Assessment.
- Who it may be relevant to
- Registry conditions: Leptomeningeal Metastasis, Leptomeningeal Disease, Leptomeningeal Neoplasms, Leptomeningeal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Netherlands, Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other Neurological Assessment
Clinical neurological assessment performed by 2 raters
Primary outcome measures
- inter-observer agreement of response assessment of the overall clinical assessment - per center and among all raters [Time frame: December 2026]
Secondary outcome measures (5)
- inter-observer reproducibility (agreement) for each item - per center and among all raters [Time frame: December 2026]
- association between items [Time frame: December 2026]
- variability of the interobserver agreement [Time frame: December 2026]
- description of clinical neurological symptoms and signs [Time frame: December 2026]
- association of clinical response with imaging and CSF cytology response and the overall global clinical/MRI/CSF response [Time frame: December 2026]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- MD Anderson Cancer Center — Houston
Netherlands · 1 center
- Netherlands Cancer Institute — Amsterdam
Switzerland · 1 center
- University Hospital Zurich — Zurich
Publications
- 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
Identifiers
NCT: NCT06417710 · NANO-LM-01