Nitride-Based Raman Biochip for Lung Cancer Diagnosis and Monitoring
NCT07755020 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 3000
Last updated 2026-08-10
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.
Conditions
- Lung Cancer (Diagnosis)
- Lung Neoplasms
Sponsors & Collaborators
-
Far Eastern Memorial Hospital
collaborator OTHER -
Taoyuan General Hospital, Ministry of Health and Welfare
collaborator OTHER_GOV -
Taichung Veterans General Hospital
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-04
- Primary Completion
- 2032-12-31
- Completion
- 2032-12-31
Countries
- Taiwan
Study Locations
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