NCT06417710RecruitingNot Applicable
Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis
University of Zurich3 sites in 3 countries200 target enrollmentStarted: January 30, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Zurich
- Enrollment
- 200
- Locations
- 3
- Primary Endpoint
- inter-observer agreement of response assessment of the overall clinical assessment - per center and among all raters
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
inter-observer agreement of response assessment of the overall clinical assessment - per center and among all raters
Time Frame: December 2026
Secondary Outcomes
- inter-observer reproducibility (agreement) for each item - per center and among all raters(December 2026)
- variability of the interobserver agreement(December 2026)
- association between items(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)
Investigators
Study Sites (3)
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