Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06417710
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Zurich
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Netherlands, Switzerland, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Leptomeningeal Metastasis, Leptomeningeal Disease, Leptomeningeal Neoplasms, Leptomeningeal Cancer

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

MD Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

MD Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Barbara O'Brien

[email protected]

832-837-9347

International Sites

Netherlands Cancer Institute, Amsterdam, Netherlands

Status

Recruiting

Address

Netherlands Cancer Institute

Amsterdam, ,

Site Contact

Dieta Bransdma

[email protected]

+31 (0)20 512 9111

University Hospital Zurich, Zurich, Switzerland

Status

Recruiting

Address

University Hospital Zurich

Zurich, ,

Site Contact

Emilie Le Rhun

[email protected]

+41 44 255 38 99

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