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NCT06417710 Clinical Trial

Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis

Leptomeningeal Metastasis Clinical Trial

— NANO-LM  

Official title:
Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06417710
Other study ID # NANO-LM-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 30, 2022
Est. completion date December 2026

Study information
Verified date May 2024
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 2026
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Neurological Assessment
Clinical neurological assessment performed by 2 raters

Locations
Country Name City State
Netherlands Netherlands Cancer Institute Amsterdam
Switzerland University Hospital Zurich Zurich
United States MD Anderson Cancer Center Houston Texas

Sponsors (3)
Lead Sponsor Collaborator
University of Zurich M.D. Anderson Cancer Center, The Netherlands Cancer Institute

Countries where clinical trial is conducted

United States,  Netherlands,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary inter-observer agreement of response assessment of the overall clinical assessment - per center and among all raters December 2026
Secondary inter-observer reproducibility (agreement) for each item - per center and among all raters December 2026
Secondary association between items December 2026
Secondary variability of the interobserver agreement December 2026
Secondary description of clinical neurological symptoms and signs December 2026
Secondary association of clinical response with imaging and CSF cytology response and the overall global clinical/MRI/CSF response December 2026
See also
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Not yet recruiting NCT06296745 - Intrathecal Pemetrexed for Leptomeningeal Metastasis From Lung Adenocarcinoma That Progressed After Osimertinib. Phase 2
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Not yet recruiting NCT04356118 - Efficacy and Safety of Recombinant Human Endostatin in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis Phase 4