NCT07912723Active, not recruiting
SERS-Based Diagnosis of Leptomeningeal Metastasis in EGFR-Mutant NSCLC
Development and Validation of a SERS-based Diagnostic Approach for Leptomeningeal Metastasis in EGFR-mutant Advanced NSCLC: a Prospective Multicenter Study
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 74 (estimated)
- First submitted
- 14 Sept 2026
- Start date
- 24 Jan 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- limeifang
- Diseases
- Lung cancer
- NCT number
- NCT07912723
What you commit to
- Study type: Observational
- Planned participants: 74
- From 24 Jan 2026 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| the 900th Hospital of the Joint Logistics Support Force; Fujian Cancer Hospital; Fujian Provincial People's Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.