NCT07755020 Nitride-Based Raman Biochip for Lung Cancer Diagnosis and Monitoring
| NCT ID | NCT07755020 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Taichung Veterans General Hospital |
| Condition | Lung Cancer (Diagnosis) |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2025-08-04 |
| Primary Completion | 2032-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2025-08-04 with a primary completion date of 2032-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07755020 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Cancer (Diagnosis). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07755020 currently recruiting?
Yes, NCT07755020 is actively recruiting participants. Contact the research team at yetquen@gmail.com for enrollment information.
Where is the NCT07755020 trial being conducted?
This trial is being conducted at Taichung, Taiwan.
Who is sponsoring the NCT07755020 clinical trial?
NCT07755020 is sponsored by Taichung Veterans General Hospital. The trial plans to enroll 3,000 participants.
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