Nitride-Based Raman Biochip for Lung Cancer Diagnosis and Monitoring

NCT07755020 | Recruiting

• 1 other identifier: CG25334B
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer (Diagnosis); Lung Neoplasms

Keywords

Nitride-based Raman biochip; Raman spectroscopy; Surface-enhanced Raman scattering; Lung cancer diagnosis; Blood biomarker; Molecular fingerprint; Clinical monitoring; Artificial intelligence; Diagnostic accuracy

Outcome Measures

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.

  At analysis of the blood sample collected at study enrollment

Secondary Outcomes (3)

• Sensitivity of the Nitride-Based Raman Biochip for Lung Cancer

  At analysis of the blood sample collected at study enrollment

• Specificity of the Nitride-Based Raman Biochip for Lung Cancer

  At analysis of the blood sample collected at study enrollment

• Positive and Negative Predictive Values of the Raman Biochip

  At analysis of the blood sample collected at study enrollment

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead
• Far Eastern Memorial Hospital: collaborator
• Taoyuan General Hospital, Ministry of Health and Welfare: collaborator

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 407219, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Approximately 20 mL of peripheral blood will be collected from each participant. Plasma will be separated by centrifugation and stored under appropriate conditions. A portion of the plasma will be analyzed using the nitride-based Raman biochip, and remaining specimens will be stored at the participating study sites. For eligible participants undergoing surgery at Taichung Veterans General Hospital, residual tissue specimens may also be retained with participant consent for future research analyses.

MeSH Terms

Conditions

Lung Neoplasms; Disease

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

CRC, MSC

CONTACT

886 4-23592525 #6535; yetquen@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Clinical Trials, Department of Medical Research

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start: August 4, 2025
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2032
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)