Clinical trial · Observational
Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis
NCT06417710CI-TRIAL-00077203NANO-LMrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leptomeningeal Cancer | Malignant Leptomeningeal Neoplasm | ALIAS | 0.90 |
| Leptomeningeal Disease | Leptomeningeal Neoplasm | ALIAS | 0.90 |
| Leptomeningeal Metastasis | — | UNRESOLVED | — |
| Leptomeningeal Neoplasms | Leptomeningeal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neurological Assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- inter-observer agreement of response assessment of the overall clinical assessment - per center and among all raters
- timeFrame
- December 2026
Secondary outcomes (5)
- measure
- inter-observer reproducibility (agreement) for each item - per center and among all raters
- timeFrame
- December 2026
- measure
- association between items
- timeFrame
- December 2026
- measure
- variability of the interobserver agreement
- timeFrame
- December 2026
- measure
- description of clinical neurological symptoms and signs
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLe 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