Blood test using a Raman biochip to help detect and monitor lung cancer
Studies a blood-based biochip for detecting lung cancer in adults with and without it.
Key facts
- Who runs it
- Taichung Veterans General Hospital
- Where
- Taichung, TaiwanSee the site
- Trial code
- Registry title
- Nitride-Based Raman Biochip for Lung Cancer Diagnosis and Monitoring
- Status
- Recruiting
- People taking part
- 3,000 people, planned
- Started
- 4 Aug 2025
- Expected to end
- 31 Dec 2032
- Type of study
- Observational, 2 groups
- Record updated
- 10 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with confirmed lung cancer, and adults without lung cancer. Blood samples are tested with a Raman biochip.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Lung cancer group: proven lung cancer of type adenocarcinoma, squamous cell carcinoma, or small cell lung cancer. Non-lung cancer group: no lung nodule or ground-glass lesion, or one smaller than 0.4 cm (0.2 in).
Main reasons for not taking part
- Younger than 18 years
- Cannot understand the study information or give written consent
- Non-lung cancer group: lung nodule or ground-glass lesion larger than 0.4 cm (0.2 in)
- Unwilling to give a blood sample
- Unwilling to allow linkage with the National Health Insurance research data system
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- 1. Younger than 18 years of age. 2. Unable to understand the study information or provide written informed consent; For the non-lung cancer group, presence of a pulmonary nodule or ground-glass lesion greater than 0.4 cm; Unwilling to provide a peripheral blood sample. 5. Unwilling to permit linkage with the National Health Insurance research data system
Where in Taiwan
- Taichung Veterans General HospitalTaichung, TaiwanContact: Pin-KueiTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- 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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Utilizing a Nitride-Based Raman Biochip for Assisting in Lung Cancer Diagnosis and Clinical Monitoring: A Prospective, Multicenter Clinical Study
- Plain-language title
- Blood test using a Raman biochip to help detect and monitor lung cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 10 August 2026