Leptomeningeal Metastasis, Leptomeningeal Disease, Leptomeningeal Neoplasms, Leptomeningeal Cancer
Conditions
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.
Interventions
Clinical neurological assessment performed by 2 raters
Sponsors
M.D. Anderson Cancer Center
The Netherlands Cancer Institute
University of Zurich
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| inter-observer agreement of response assessment of the overall clinical assessment - per center and among all raters | December 2026 |
Secondary
| 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 |
Countries
Netherlands, Switzerland, United States
Outcome results
None listed