Meningeal MetastasisCLM-tree databNCT06718972
A Real-world Study on the Treatment of Non-small Cell Lung Cancer With Leptomeningeal Metastasis in China
An observational study of Meningeal Metastasis and Non-Small Cell Lung Cancer, run by Guangzhou Medical University at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Meningeal Metastasis, Non-Small Cell Lung Cancer
- What is being tested?
- Not applicable- observational study
- How many people
- 1,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 Sep 2024to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: non-small cell lung cancer patients with Leptomeningeal metastases
Who may be able to join
- non-small cell lung cancer patients with Leptomeningeal metastases diagnosed after January 2018;
- Patients who underwent antitumor therapy after diagnosis of LM.
Who cannot join
- Patients with small cell lung cancer components;
- complicated with tumors other than non-small cell lung cancer.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Guangdong Sanjiu Brain Hospital
Guangzhou, Guangdong, 510000
chief physician
- Recruiting
the First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
chief physician, 13711244230, bjrf2009@yahoo.com
About this study
Official title: Database of 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.
Read the detailed description
retrospective and prospective study
- Conditions
- Meningeal Metastasis, Non-Small Cell Lung Cancer
- Being tested
- Not applicable- observational study
- Keywords
- Non-Small Cell Lung Cancer, meningeal metastasis, real-world study, database
- Medical subject headings
- Meningeal Carcinomatosis, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
This is a retrospective and observational study. Not Applicable
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival(OS)
Measured: 6 years
Secondary outcomes (3)
Time to failure(TTF)
Measured: 6 years
Change in cerebrospinal fluid and metabolic markers during treatment
Measured: 6 years
Safety during actual clinical treatment
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Sep 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningeal MetastasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haihong Yang, MD, Pricipal investigator, Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718972
- Sponsor's protocol ID
- ES-2024-K125-02
- Acronym
- CLM-tree datab
- Status last verified
- Apr 2025
- First submitted
- 27 Nov 2024
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Database of Real-world Study on the Treatment of Non-small Cell Lung Cancer With Leptomeningeal Metastasis in China
- ClinicalTrials.gov ID
- NCT06718972
- Acronym / sponsor ID
- CLM-tree datab / ES-2024-K125-02
- Conditions
- Meningeal Metastasis, Non-Small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, meningeal metastasis, real-world study, database
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- non-small cell lung cancer patients with Leptomeningeal metastases
Key inclusion criteria (2 listed)
- non-small cell lung cancer patients with Leptomeningeal metastases diagnosed after January 2018;
- Patients who underwent antitumor therapy after diagnosis of LM.
Key exclusion criteria (2 listed)
- Patients with small cell lung cancer components;
- complicated with tumors other than non-small cell lung cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable- observational studyThis is a retrospective and observational study. Not Applicable | Other | – |
Primary outcome
Overall survival(OS)
Time frame: 6 years
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningeal Metastasis and Non-Small Cell Lung Cancer, run by Guangzhou Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact hong hai Yang (13711244230, bjrf2009@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival(OS) (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.