Standardized Clinical Assessment of Patients With Leptome... | NCT06417710

Studies
Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis

NCT06417710

Sponsor

University of Zurich

Status

Recruiting

Last Update Posted

May 16, 2024Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Leptomeningeal Metastasis
Leptomeningeal Disease
Leptomeningeal Neoplasms
Leptomeningeal Cancer

Interventions

Neurological Assessment

Countries

United States
Netherlands
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 30, 2022Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

May 12, 2024

First Submission Date that Met QC Criteria

May 12, 2024

First Posted Date

May 16, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2024

Last Update Posted Date

May 16, 2024Actual

Name	Class
M.D. Anderson Cancer Center	OTHER
The Netherlands Cancer Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neurological Assessment	Other	Clinical neurological assessment performed by 2 raters

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
inter-observer agreement of response assessment of the overall clinical assessment - per center and among all raters		December 2026

Secondary Outcomes

Measure	Description	Time Frame
inter-observer reproducibility (agreement) for each item - per center and among all raters		December 2026
association between items		December 2026
variability of the interobserver agreement

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with leptomeningeal metastases from various extra-central nervous system (CNS) solid primary tumors for whom a tumor-specific treatment is planned

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MD Anderson Cancer Center	Recruiting	Houston	Texas	77030	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39208403	Derived	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.

ID	Term
D055756	Meningeal Carcinomatosis
D008577	Meningeal Neoplasms

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms