Clinical trial · Observational
Nitride-Based Raman Biochip for Lung Cancer Diagnosis and Monitoring
Utilizing a Nitride-Based Raman Biochip for Assisting in Lung Cancer Diagnosis and Clinical Monitoring: A Prospective, Multicenter Clinical Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer (Diagnosis) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Lung Cancer Group
- description
- Adult participants with pathologically confirmed lung cancer, including adenocarcinoma, squamous cell carcinoma, or small cell lung cancer. Participants will provide peripheral blood samples annually for three years for Raman biochip testing and biomarker analysis.
- label
- Non-Lung Cancer Group
- description
- Adult participants without a diagnosis of lung cancer who underwent low-dose computed tomography or chest computed tomography within the previous two years and who have no pulmonary nodule or ground-glass lesion, or a lesion smaller than 0.4 cm. Participants may have chronic pulmonary diseases such as chronic obstructive pulmonary disease, asthma, bronchiectasis, or pulmonary fibrosis. One peripheral blood sample will be collected at enrollment.
Primary outcomes (1)
- measure
- Diagnostic Accuracy of the Nitride-Based Raman Biochip for Lung Cancer
- timeFrame
- At analysis of the blood sample collected at study enrollment
- description
- The ability of the Raman spectral signature generated by the nitride-based Raman biochip to distinguish participants with pathologically confirmed lung cancer from participants without lung cancer will be evaluated using the area under the receiver operating characteristic curve.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Lung Cancer Group: 1. Age 18 years or older. 2. Underwent low-dose computed tomography or chest computed tomography within the previous 2 years. 3. Pathologically confirmed lung cancer. 4. Histological diagnosis of adenocarcinoma, squamous cell carcinoma, or small cell lung cancer, with TNM stage determined by a thoracic physician. 5. Willing to provide approximately 20 mL of peripheral blood annually for 3 years. 6. Able to understand the study information and provide written informed consent. 7. Agrees to linkage of study data with relevant health insurance and mortality databases, as applicable. Non-Lung Cancer Group: 1. Age 18 years or older. 2. Underwent low-dose computed tomography or chest computed tomography within the previous 2 years. 3. No pulmonary nodule or ground-glass lesion, or a pulmonary nodule or ground-glass lesion smaller than 0.4 cm. 4. May have a chronic pulmonary disease, including chronic obstructive pulmonary disease, asthma, bronchiectasis, or pulmonary fibrosis. 5. Willing to provide one peripheral blood sample of approximately 20 mL. 6. Able to understand the study information and provide written informed consent. 7. Agrees to linkage of study data with relevant health insurance and mortality databases, as applicable. Exclusion Criteria: * 1\. Younger than 18 years of age. 2. Unable to understand the study information or provide written informed consent. 3\. For the non-lung cancer group, presence of a pulmonary nodule or ground-glass lesion greater than 0.4 cm. 4\. Unwilling to provide a peripheral blood sample. 5. Unwilling to permit linkage with the National Health Insurance research data system.
References
Publications (0)
Data not yet available