An observational study in Lung Cancer (Diagnosis) and Lung Neoplasms, sponsored by Taichung Veterans General Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Taichung Veterans General Hospital · Observational
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.
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.
5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 200 across 1,434 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Taichung Veterans General Hospital is the lead sponsor of 175 studies on the registry; 39 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Lung Cancer Group:
Non-Lung Cancer Group:
Exclusion Criteria:
1. Younger than 18 years of age. 2. Unable to understand the study information or provide written .
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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 enrollment
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 enrollment
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 enrollment
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 enrollment
Plan to share: No — Individual participant data are not currently planned for public sharing because the study includes sensitive clinical information, biospecimen-derived data, and linked health insurance and mortality data. De-identified aggregate results may be reported in scientific publications.
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Dec 2032, 88 months after the start.
Of 591 non-industry observational studies under Lung Neoplasms, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 162. This study's planned 88 months is above that.
Counting every sponsor, half of 681 studies reached it within 57 months; a quarter within 25 and three quarters within 135.
How these figures are worked out, and which studies are left out of them.
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