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NCT Number: NCT06718972

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

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.

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Key information

Conditions

Meningeal Metastasis Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Central Nervous System Neoplasms Lung Diseases Lung Neoplasms Meningeal Carcinomatosis Meningeal Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Non-small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangdong Sanjiu Brain Hospital, Guangzhou, Guangdong, China

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About this study

retrospective and prospective study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Not applicable- observational study

Other

This is a retrospective and observational study. Not Applicable

Primary outcomes

  1. Overall survival(OS)

    Time frame: 6 years

Secondary outcomes

  1. Time to failure(TTF)

    Time frame: 6 years

  2. Change in cerebrospinal fluid and metabolic markers during treatment

    Time frame: 6 years

  3. Safety during actual clinical treatment

    Time frame: 6 years

Study contacts

Contact information is provided by the study sponsor or research team.

hong hai Yang

CONTACT

[email protected]

13711244230

Sponsors and collaborators

Lead sponsor

Guangzhou Medical University

Other

Registry information

Official study title

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

Acronym: CLM-tree datab

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Dec 5, 2024
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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