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Recruiting NCT06718972

A Real-world Study on the Treatment of Non-small Cell Lung Cancer With Leptomeningeal Metastasis in China

Observational Meningeal Metastasis Non-Small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Not applicable- observational study.
Who it may be relevant to
Registry conditions: Meningeal Metastasis, Non-Small Cell Lung Cancer. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Database of Real-world Study on the Treatment of Non-small Cell Lung Cancer With Leptomeningeal Metastasis in China

Overview

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.

Detailed description

retrospective and prospective study

Interventions

  • Other Not applicable- observational study
    This is a retrospective and observational study. Not Applicable

Primary outcome measures

  • Overall survival(OS) [Time frame: 6 years]
Secondary outcome measures (3)
  • Time to failure(TTF) [Time frame: 6 years]
  • Change in cerebrospinal fluid and metabolic markers during treatment [Time frame: 6 years]
  • Safety during actual clinical treatment [Time frame: 6 years]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 2 centers
  • Guangdong Sanjiu Brain Hospital — Guangzhou
  • the First Affiliated Hospital of Guangzhou Medical University — Guangzhou

Identifiers

NCT: NCT06718972 · ES-2024-K125-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗