A Real-world Study on the Treatment of Non-small Cell Lun... | NCT06718972

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

NCT06718972

Sponsor

Guangzhou Medical University

Status

Recruiting

Last Update Posted

Apr 27, 2025Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Meningeal Metastasis
Non-Small Cell Lung Cancer

Interventions

Not applicable- observational study

Countries

China

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

Apr 2025

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

Sep 1, 2024Actual

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Nov 27, 2024

First Submission Date that Met QC Criteria

Dec 2, 2024

First Posted Date

Dec 5, 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

Apr 24, 2025

Last Update Posted Date

Apr 27, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Haihong Yang, MD, Pricipal investigator, Chief Physician, Guangzhou Medical UniversityPrincipal Investigator

Lead Sponsor

Guangzhou Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

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

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

Retention

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Not applicable- observational study	Other	This is a retrospective and observational study. Not Applicable

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival(OS)		6 years

Secondary Outcomes

Measure	Description	Time Frame
Time to failure(TTF)		6 years
Change in cerebrospinal fluid and metabolic markers during treatment		6 years
Safety during actual clinical treatment

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

non-small cell lung cancer patients with Leptomeningeal metastases

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
hong hai Yang	Contact	13711244230		bjrf2009@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Guangdong Sanjiu Brain Hospital	Recruiting	Guangzhou	Guangdong	510000	China

Condition Browse Module

MeSH Terms

ID	Term
D055756	Meningeal Carcinomatosis
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D008577	Meningeal Neoplasms
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided