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RECRUITING
NCT07755020

Nitride-Based Raman Biochip for Lung Cancer Diagnosis and Monitoring

Sponsor: Taichung Veterans General Hospital

View on ClinicalTrials.gov

Summary

This prospective, multicenter observational study aims to evaluate the diagnostic and clinical monitoring performance of a nitride-based Raman biochip in participants with and without lung cancer. Peripheral blood samples will be collected and analyzed using the Raman biochip to characterize molecular spectral patterns and assess their association with the current standard diagnosis of lung cancer. The study plans to enroll 2,000 participants with pathologically confirmed lung cancer and 1,000 participants without lung cancer. Diagnostic performance will be evaluated using measures including sensitivity, specificity, positive predictive value, negative predictive value, and receiver operating characteristic curve analysis. Exploratory analyses will assess performance according to lung cancer histological subtype, disease stage, and longitudinal clinical status.

Official title: Utilizing a Nitride-Based Raman Biochip for Assisting in Lung Cancer Diagnosis and Clinical Monitoring: A Prospective, Multicenter Clinical Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

3000

Start Date

2025-08-04

Completion Date

2032-12-31

Last Updated

2026-08-10

Healthy Volunteers

No

Locations (1)

Taichung Veterans General Hospital

Taichung, Taiwan