Lung Adenocarcinoma EGFR-mutatedSERSNCT07912723
SERS-Based Diagnosis of Leptomeningeal Metastasis in EGFR-Mutant NSCLC
An observational study of Lung Adenocarcinoma EGFR-mutated and Leptomeningeal Metastasis From Lung Cancer, run by limeifang at 1 site in China.
Trial summary
This prospective, multicenter study aims to address the low sensitivity of cerebrospinal fluid (CSF) cytology (60-70%) in diagnosing leptomeningeal metastasis (LM) in patients with EGFR-mutant lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Adenocarcinoma EGFR-mutated, Leptomeningeal Metastasis From Lung Cancer
- What is being tested?
- Surface-Enhanced Raman Spectroscopy (SERS) Detection
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 24 Jan 2026to 30 Jun 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants will be recruited from outpatient clinics and inpatient wards across three tertiary hospitals. The target population comprises patients with advanced non-small cell lung cancer (NSCLC) who have been histologically or cytologically confirmed to harbor EGFR-sensitive mutations, and who have leptomeningeal metastasis verified by cerebrospinal fluid (CSF) cytology. Both treatment-naïve patients and those who have undergone prior systemic anti-tumor therapy are eligible. All participants must be aged 18 years or older, have comprehensive clinical records accessible, and voluntarily sign the informed consent form.
Who may be able to join
- Age ≥ 18 years; Pathologically confirmed NSCLC; EGFR-sensitive mutations (19del, L858R, or uncommon mutations); Positive CSF cytology for malignant cells; No prior treatment or prior systemic therapy allowed; Complete medical records available (demographics, pathology, molecular pathology, imaging); Signed informed consent and willingness to complete the study.
Who cannot join
- Pathologically confirmed mixed histology containing small cell lung cancer (SCLC) components; Presence of other primary malignancies other than lung cancer; Molecular pathology indicating concurrent other driver mutations, including ALK, ROS1, or other oncogenic alterations; Co-existing neurological diseases unrelated to the tumor; Severe cardiac or pulmonary dysfunction; Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
China1 site
the 900th Hospital of the Joint Logistics Support Force; Fujian Cancer Hospital; Fujian Provincial People's Hospital
Fuzhou, Fujian, 350000
About this study
Official title: Development and Validation of a SERS-based Diagnostic Approach for Leptomeningeal Metastasis in EGFR-mutant Advanced NSCLC: a Prospective Multicenter Study
This prospective, multicenter study aims to address the low sensitivity of cerebrospinal fluid (CSF) cytology (60-70%) in diagnosing leptomeningeal metastasis (LM) in patients with EGFR-mutant lung cancer. We will establish a diagnostic methodology and develop a predictive model using surface-enhanced Raman spectroscopy (SERS) technology to improve diagnostic accuracy and guide subsequent clinical management.
- Being tested
- Surface-Enhanced Raman Spectroscopy (SERS) Detection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surface-Enhanced Raman Spectroscopy (SERS) DetectionDiagnostic test
In this study, cerebrospinal fluid (CSF) samples are analyzed using surface-enhanced Raman spectroscopy (SERS). SERS is a highly sensitive spectroscopic technique based on nanostructured metallic substrates, capable of capturing characteristic "molecular fingerprint" signals from trace amounts of metabolites, proteins, nucleic acids, and other biomolecules released by tumor cells into the CSF.Detection procedure: CSF specimens are collected from participants via lumbar puncture. After centrifugation, the supernatant is deposited onto a SERS-active substrate, and Raman scattering spectra are acquired under laser excitation. The acquired spectral data undergo preprocessing steps including baseline correction, smoothing, and noise reduction, followed by extraction of characteristic peak information.
What is being measured
The primary outcome is the main question the study is designed to answer.
SERS signal characteristics and the formation of fingerprint spectra
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start24 Jan 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Adenocarcinoma EGFR-mutatedStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- limeifang
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, limeifang, Fujian Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912723
- Sponsor's protocol ID
- LCLM-01
- Acronym
- SERS
- Status last verified
- Aug 2026
- First submitted
- 14 Sep 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a SERS-based Diagnostic Approach for Leptomeningeal Metastasis in EGFR-mutant Advanced NSCLC: a Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT07912723
- Acronym / sponsor ID
- SERS / LCLM-01
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- limeifangOther government
- Study start
- 24 Jan 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 3 Nov 2026 (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 prospective, multicenter study aims to address the low sensitivity of cerebrospinal fluid (CSF) cytology (60-70%) in diagnosing leptomeningeal metastasis (LM) in patients with EGFR-mutant lung cancer. We will establish a diagnostic methodology and develop a predictive model using surface-enhanced Raman spectroscopy (SERS) technology to improve diagnostic accuracy and guide subsequent clinical management.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be recruited from outpatient clinics and inpatient wards across three tertiary hospitals. The target population comprises patients with advanced non-small cell lung cancer (NSCLC) who have been histologically or cytologically confirmed to harbor EGFR-sensitive mutations, and who have leptomeningeal metastasis verified by cerebrospinal fluid (CSF) cytology. Both treatment-naïve patients and those who have undergone prior systemic anti-tumor therapy are eligible. All participants must be aged 18 years or older, have comprehensive clinical records accessible, and voluntarily sign the informed consent form.
Key inclusion criteria (1 listed)
- Age ≥ 18 years; Pathologically confirmed NSCLC; EGFR-sensitive mutations (19del, L858R, or uncommon mutations); Positive CSF cytology for malignant cells; No prior treatment or prior systemic therapy allowed; Complete medical records available (demographics, pathology, molecular pathology, imaging); Signed informed consent and willingness to complete the study.
Key exclusion criteria (1 listed)
- Pathologically confirmed mixed histology containing small cell lung cancer (SCLC) components; Presence of other primary malignancies other than lung cancer; Molecular pathology indicating concurrent other driver mutations, including ALK, ROS1, or other oncogenic alterations; Co-existing neurological diseases unrelated to the tumor; Severe cardiac or pulmonary dysfunction; Pregnancy or lactation.
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 |
|---|---|---|
| Surface-Enhanced Raman Spectroscopy (SERS) DetectionIn this study, cerebrospinal fluid (CSF) samples are analyzed using surface-enhanced Raman spectroscopy (SERS). SERS is a highly sensitive spectroscopic technique based on nanostructured metallic substrates, capable of capturing characteristic "molecular fingerprint" signals from trace amounts of metabolites, proteins, nucleic acids, and other biomolecules released by tumor cells into the CSF.Detection procedure: CSF specimens are collected from participants via lumbar puncture. After centrifugation, the supernatant is deposited onto a SERS-active substrate, and Raman scattering spectra are acquired under laser excitation. The acquired spectral data undergo preprocessing steps including baseline correction, smoothing, and noise reduction, followed by extraction of characteristic peak information. | Diagnostic test | – |
Primary outcome
SERS signal characteristics and the formation of fingerprint spectra
Time frame: Baseline
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 3 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Adenocarcinoma EGFR-mutated and Leptomeningeal Metastasis From Lung Cancer, run by limeifang at 1 site 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SERS signal characteristics and the formation of fingerprint spectra (time frame: Baseline). 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 3 Nov 2026.