Utilizing a Nitride-Based Raman Biochip for Assisting in Lung Cancer Diagnosis and Clinical Monitoring: A Prospective, Multicenter Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Diagnostic Accuracy of the Nitride-Based Raman Biochip for Lung Cancer
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •1. Younger than 18 years of age.
- •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.
- •Unwilling to permit linkage with the National Health Insurance research data system.
研究组 & 干预措施
Lung Cancer Group
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.
Non-Lung Cancer Group
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.
结局指标
主要结局
Diagnostic Accuracy of the Nitride-Based Raman Biochip for Lung Cancer
时间窗: At analysis of the blood sample collected at study enrollment
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.
次要结局
- Sensitivity of the Nitride-Based Raman Biochip for Lung Cancer(At analysis of the blood sample collected at study enrollment)
- Specificity of the Nitride-Based Raman Biochip for Lung Cancer(At analysis of the blood sample collected at study enrollment)
- Positive and Negative Predictive Values of the Raman Biochip(At analysis of the blood sample collected at study enrollment)
研究者
Pin-Kuei Fu, MD, PhD
Director, Division of Clinical Trials, Department of Medical Research
Taichung Veterans General Hospital