Nitride-Based Raman Biochip for Lung Cancer Diagnosis and Monitoring
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTaichung Veterans General Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
1. Younger than 18 years of age. 2. Unable to understand the study information or provide written informed consent.
Trial population
Adult patients receiving clinical care at Taichung Veterans General Hospital, Far Eastern Memorial Hospital, or Taoyuan General Hospital, Ministry of Health and Welfare, who underwent low-dose computed tomography or chest computed tomography within the previous two years. The study population will include participants with pathologically confirmed lung cancer and participants without lung cancer who meet the radiological eligibility criteria.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
3,000 Participants
are grouped into 2 trial groupsGroup A: Lung Cancer Group
Group B: Non-Lung Cancer Group
Trial outcomes
Primary outcomes
1
Diagnostic Accuracy of the Nitride-Based Raman Biochip for Lung Cancer
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.
Time frame
At analysis of the blood sample collected at study enrollmentSecondary outcomes
1
Sensitivity of the Nitride-Based Raman Biochip for Lung Cancer
The proportion of participants with pathologically confirmed lung cancer who are classified as positive by the Raman biochip at the study-defined spectral cutoff.
Time frame
At analysis of the blood sample collected at study enrollment2
Specificity of the Nitride-Based Raman Biochip for Lung Cancer
The proportion of participants without lung cancer who are classified as negative by the Raman biochip at the study-defined spectral cutoff.
Time frame
At analysis of the blood sample collected at study enrollment3
Positive and Negative Predictive Values of the Raman Biochip
Positive predictive value and negative predictive value of the Raman biochip classification for lung cancer will be calculated using the study-defined spectral cutoff.
Time frame
At analysis of the blood sample collected at study enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Taichung Veterans General Hospital
Lead sponsor
Far Eastern Memorial Hospital
Collaborator
Taoyuan General Hospital, Ministry of Health and Welfare
Collaborator
Source ClinicalTrials.gov