Lung Cancer (Diagnosis)NCT07755020
Nitride-Based Raman Biochip for Lung Cancer Diagnosis and Monitoring
An observational study of Lung Cancer (Diagnosis) and Lung Neoplasms, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (Diagnosis), Lung Neoplasms
- How many people
- 3,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Aug 2025to 31 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 16Show fewer
- 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 join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, 407219
Pin-Kuei
About this study
Official title: Utilizing a Nitride-Based Raman Biochip for Assisting in Lung Cancer Diagnosis and Clinical Monitoring: A Prospective, Multicenter Clinical Study
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.
Read the detailed description
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.
- 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
- Medical subject headings
- Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At analysis of the blood sample collected at study enrollment
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: At analysis of the blood sample collected at study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start4 Aug 2025
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Far Eastern Memorial Hospital, Taoyuan General Hospital
- Responsible party
- Principal investigator, Pin-Kuei Fu, MD, PhD, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755020
- Sponsor's protocol ID
- CG25334B
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing a Nitride-Based Raman Biochip for Assisting in Lung Cancer Diagnosis and Clinical Monitoring: A Prospective, Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT07755020
- Acronym / sponsor ID
- CG25334B
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Collaborators
- Far Eastern Memorial Hospital, Taoyuan General Hospital
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Accuracy of the Nitride-Based Raman Biochip for Lung Cancer
Time frame: At analysis of the blood sample collected at study enrollment
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.
3 secondary outcomes
Sensitivity of the Nitride-Based Raman Biochip for Lung Cancer
Time frame: At analysis of the blood sample collected at study enrollment
Specificity of the Nitride-Based Raman Biochip for Lung Cancer
Time frame: At analysis of the blood sample collected at study enrollment
Positive and Negative Predictive Values of the Raman Biochip
Time frame: At analysis of the blood sample collected at study enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer (Diagnosis) and Lung Neoplasms, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CRC, MSC (886 4-23592525 #6535, yetquen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of the Nitride-Based Raman Biochip for Lung Cancer (time frame: At analysis of the blood sample collected at study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.