Overview
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.
Description
Lung cancer diagnosis currently relies on imaging examinations, histopathological evaluation, and molecular testing. Although low-dose computed tomography can detect early pulmonary lesions, false-positive findings may lead to additional examinations and patient anxiety. Additional noninvasive biomarkers may therefore help support clinical assessment.
Raman scattering provides a molecular spectral fingerprint. The nitride-based Raman biochip evaluated in this study uses InGaN quantum-well technology to enhance Raman signals and generate spectral patterns from blood samples. Previous preliminary research suggested that blood samples from patients with lung cancer may demonstrate characteristic spectral distributions.
This is a prospective, multicenter, investigator-initiated observational study conducted in Taiwan. Participants will be classified into a lung cancer group or a non-lung cancer group according to clinical, radiological, and pathological findings. The study will enroll approximately 2,000 participants with lung cancer and 1,000 participants without lung cancer.
Participants in the lung cancer group will provide approximately 20 mL of peripheral blood annually for three years. Participants in the non-lung cancer group will provide approximately 20 mL of peripheral blood at enrollment. If a participant in the non-lung cancer group is subsequently diagnosed with lung cancer, subsequent blood sampling will follow the schedule for the lung cancer group.
Raman biochip results will be compared between the lung cancer and non-lung cancer groups. Diagnostic performance will be evaluated using receiver operating characteristic curves, sensitivity, specificity, positive predictive value, and negative predictive value. Additional analyses will evaluate performance according to histological subtype, cancer stage, early-stage disease, and longitudinal changes associated with treatment and disease status.
Eligibility
Inclusion Criteria:
- Lung Cancer Group:
- Age 18 years or older.
- Underwent low-dose computed tomography or chest computed tomography within the previous 2 years.
- Pathologically confirmed lung cancer.
- Histological diagnosis of adenocarcinoma, squamous cell carcinoma, or small cell lung cancer, with TNM stage determined by a thoracic physician.
- Willing to provide approximately 20 mL of peripheral blood annually for 3 years.
- Able to understand the study information and provide written informed consent.
- Agrees to linkage of study data with relevant health insurance and mortality databases, as applicable.
Non-Lung Cancer Group:
- Age 18 years or older.
- Underwent low-dose computed tomography or chest computed tomography within the previous 2 years.
- No pulmonary nodule or ground-glass lesion, or a pulmonary nodule or ground-glass lesion smaller than 0.4 cm.
- May have a chronic pulmonary disease, including chronic obstructive pulmonary disease, asthma, bronchiectasis, or pulmonary fibrosis.
- Willing to provide one peripheral blood sample of approximately 20 mL.
- Able to understand the study information and provide written informed consent.
- 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.
