NCT07755020Recruiting
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 · Last updated 10 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 3000 (estimated)
- First submitted
- 5 Aug 2026
- Start date
- 4 Aug 2025
- Primary completion date
- 31 Dec 2032
- Lead sponsor
- Taichung Veterans General Hospital
- Diseases
- Lung cancer
- NCT number
- NCT07755020
What you commit to
- Study type: Observational
- Planned participants: 3000
- From 4 Aug 2025 to the primary completion date, 31 Dec 2032
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.