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SERS-Based Serum Molecular Spectral Screening for Lung Cancer Type

NCT06775002 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 223

Last updated 2025-03-31

No results posted yet for this study

Summary

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.

Conditions

  • Lung Cancer, Non-Small Cell
  • Lung Cancer Small Cell Lung Cancer (SCLC)

Interventions

DIAGNOSTIC_TEST

Serum Raman spectroscopy intelligent diagnostic system

1\. Screening interested participants should sign the appropriate informed consent (ICF) prior to completion any study procedures. 2. The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria. 3. The following is the general sequence of events during the 3 months evaluation period. 4. Completion of baseline procedures Participants were assessed for 3 months and completed all safety monitoring.

Sponsors & Collaborators

  • Fuzhou General Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-05
Primary Completion
2026-11-20
Completion
2026-11-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06775002 on ClinicalTrials.gov