## Protocol Section
### Identification Module
**NCT ID:** NCT06417710

**Acronym:** NANO-LM

**Brief Title:** Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis

**Official Title:** Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis

#### Organization Study ID Info
**ID:** NANO-LM-01
#### Organization
**Class:** OTHER
**Full Name:** University of Zurich
### Status Module
#### Completion Date
**Date:** 2026-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-12

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-01-30

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-12
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** M.D. Anderson Cancer Center

**Class:** OTHER

**Name:** The Netherlands Cancer Institute

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Zurich

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### 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.

### Conditions Module

**Conditions:**

- Leptomeningeal Metastasis

- Leptomeningeal Disease

- Leptomeningeal Neoplasms

- Leptomeningeal Cancer

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 200

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** Clinical neurological assessment performed by 2 raters

**Name:** Neurological Assessment

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** inter-observer agreement of response assessment of the overall clinical assessment - per center and among all raters

**Time Frame:** December 2026

#### Secondary Outcomes

**Measure:** inter-observer reproducibility (agreement) for each item - per center and among all raters

**Time Frame:** December 2026

**Measure:** association between items

**Time Frame:** December 2026

**Measure:** variability of the interobserver agreement

**Time Frame:** December 2026

**Measure:** description of clinical neurological symptoms and signs

**Time Frame:** December 2026

**Measure:** association of clinical response with imaging and CSF cytology response and the overall global clinical/MRI/CSF response

**Time Frame:** December 2026

### 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.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_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

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Houston

**Contacts:**

***Contact 1:***

- **Email:** BJOBrien@mdanderson.org

- **Name:** Barbara O'Brien

- **Phone:** 832-837-9347

- **Role:** CONTACT

**Country:** United States

**Facility:** MD Anderson Cancer Center

**State:** Texas

**Status:** RECRUITING

**Zip:** 77030

**Location 2:**

**City:** Amsterdam

**Contacts:**

***Contact 1:***

- **Email:** d.brandsma@nki.nl

- **Name:** Dieta Bransdma

- **Phone:** +31 (0)20 512 9111

- **Role:** CONTACT

**Country:** Netherlands

**Facility:** Netherlands Cancer Institute

**Status:** RECRUITING

**Location 3:**

**City:** Zurich

**Contacts:**

***Contact 1:***

- **Email:** emilie.lerhun@usz.ch

- **Name:** Emilie Le Rhun

- **Phone:** +41 44 255 38 99

- **Role:** CONTACT

**Country:** Switzerland

**Facility:** University Hospital Zurich

**Status:** RECRUITING

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009385

- Term: Neoplastic Processes

- ID: D000009369

- Term: Neoplasms

- ID: D000010335

- Term: Pathologic Processes

- ID: D000016543

- Term: Central Nervous System Neoplasms

- ID: D000009423

- Term: Nervous System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M12307

- Name: Neoplasm Metastasis

- Relevance: HIGH

- As Found: Metastases

- ID: M28325

- Name: Meningeal Carcinomatosis

- Relevance: HIGH

- As Found: Leptomeningeal Metastasis

- ID: M11560

- Name: Meningeal Neoplasms

- Relevance: HIGH

- As Found: Leptomeningeal Neoplasms

- ID: M12330

- Name: Neoplastic Processes

- Relevance: LOW

- As Found: Unknown

- ID: M18937

- Name: Central Nervous System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M12367

- Name: Nervous System Neoplasms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009362

- Term: Neoplasm Metastasis

- ID: D000055756

- Term: Meningeal Carcinomatosis

- ID: D000008577

- Term: Meningeal Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
