SERS-Based Serum Molecular Spectral Screening for Lung Cancer Type

Lung cancer can be divided into two major categories: small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC), with NSCLC accounting for about 85% and SCLC about 15%. The prognoses of different types of lung cancer vary significantly. Early identification of different pathological types of lung cancer is crucial to the patient's prognosis. Raman Spectrum (RS), as a non-invasive and highly specific molecular detection technique, can obtain information at the molecular level, thereby sensitively detecting changes in biomolecules related to tumor metabolism such as proteins, nucleic acids, lipids, and sugars. Surface-enhanced Raman spectroscopy (SERS), developed based on this technology, is one of the feasible methods for high-sensitivity biomolecular analysis. In preliminary study, the investigators collected serum Raman spectral data from a cohort of 233 patients with malignant lung tumors and built a Raman intelligent diagnostic system for SCLC and NSCLC based on a machine learning model, achieving an accuracy rate of 80%. To obtain the highest level of clinical evidence and truly achieve clinical translation, this prospective, multicenter clinical study aims to validate the use of this intelligent diagnostic system for the early diagnosis of SCLC.

NCT Number	NCT06775002
Lead Sponsor	Fuzhou General Hospital
Conditions	Lung Cancer, Non-Small Cell, Lung Cancer Small Cell Lung Cancer (SCLC)
Enrollment	223 participants
Start Date	2026-04-05
Primary Completion	2026-11-20 (estimated)
Study Completion	2026-11-20 (estimated)
Updated on ClinicalTrials.gov	2025-03-31