NCT06718972

Brief Summary

This is a retrospective and prospective study planned to include NSCLC patients with Leptomeningeal metastasis (LM) and treated with antitumor therapy after 2018, from multiple centers such as the First Affiliated Hospital of Guangzhou Medical University, Guangdong Sanjiu Brain Hospital, etc., aiming to establish a database related to the treatment strategies of LM patients, and to evaluate the efficacy (eg. Overall Survival/Time to Failure) and safety of different treatment strategies of LM patients, etc., as well as the significance of concomitant testing in LM patients.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started Sep 2024

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Sep 2024Dec 2028

Study Start

First participant enrolled

September 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 5, 2024

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

4.3 years

First QC Date

November 27, 2024

Last Update Submit

April 24, 2025

Conditions

Keywords

Non-Small Cell Lung Cancermeningeal metastasisreal-world studydatabase

Outcome Measures

Primary Outcomes (1)

  • Overall survival(OS)

    6 years

Secondary Outcomes (3)

  • Time to failure(TTF)

    6 years

  • Change in cerebrospinal fluid and metabolic markers during treatment

    6 years

  • Safety during actual clinical treatment

    6 years

Interventions

This is a retrospective and observational study. Not Applicable

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

non-small cell lung cancer patients with Leptomeningeal metastases

You may qualify if:

  • non-small cell lung cancer patients with Leptomeningeal metastases diagnosed after January 2018;
  • Patients who underwent antitumor therapy after diagnosis of LM.

You may not qualify if:

  • Patients with small cell lung cancer components;
  • complicated with tumors other than non-small cell lung cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Guangdong Sanjiu Brain Hospital

Guangzhou, Guangdong, 510000, China

RECRUITING

the First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and cerebrospinal fluid

MeSH Terms

Conditions

Meningeal CarcinomatosisCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Meningeal NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

hong hai Yang

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

November 27, 2024

First Posted

December 5, 2024

Study Start

September 1, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

April 27, 2025

Record last verified: 2025-04

Locations