Nitride-Based Raman Biochip for Lung Cancer Diagnosis and Monitoring (NCT07755020) | Clinical Trial Compass
RecruitingNot Applicable
Nitride-Based Raman Biochip for Lung Cancer Diagnosis and Monitoring
Taiwan3,000 participantsStarted 2025-08-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic Accuracy of the Nitride-Based Raman Biochip for Lung Cancer
Timeframe: At analysis of the blood sample collected at study enrollment