Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis

NCT ID: NCT06417710

Last Updated: 2024-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-30

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Leptomeningeal Metastasis Leptomeningeal Disease Leptomeningeal Neoplasms Leptomeningeal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Neurological Assessment

Clinical neurological assessment performed by 2 raters

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role collaborator

The Netherlands Cancer Institute

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Netherlands Cancer Institute

Amsterdam, , Netherlands

Site Status RECRUITING

University Hospital Zurich

Zurich, , Switzerland

Site Status RECRUITING

Countries

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United States Netherlands Switzerland

Facility Contacts

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Barbara O'Brien

Role: primary

832-837-9347

Dieta Bransdma

Role: primary

+31 (0)20 512 9111

Emilie Le Rhun

Role: primary

+41 44 255 38 99

References

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Le 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.

Reference Type DERIVED
PMID: 39208403 (View on PubMed)

Other Identifiers

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NANO-LM-01

Identifier Type: -

Identifier Source: org_study_id

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