Recruiting

Observational Study

Sponsor:

University of Zurich

Code:

NCT06417710

Conditions

Leptomeningeal Metastasis

Leptomeningeal Disease

Leptomeningeal Neoplasms

Leptomeningeal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Neurological Assessment

Study Details

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.

Conditions

Leptomeningeal Metastasis

Leptomeningeal Disease

Leptomeningeal Neoplasms

Leptomeningeal Cancer

Study ID

NCT06417710

Start date

Jan 30, 2022

Status verified date

May, 2024

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Interventions

Neurological Assessment

Clinical neurological assessment performed by 2 raters

Primary outcome measure

  • inter-observer agreement of response assessment of the overall clinical assessment - per center and among all raters [ Time Frame: December 2026 ]

Central Contacts and Locations

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Barbara O'Brien

832-837-9347BJOBrien@mdanderson.org

More Information

Sponsor

University of Zurich

Last update posted

May 16, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Zurich on 2024-05-16.