Nitride-based Raman biochip for lung cancer diagnosis and monitoring

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter observational study in Taiwan enrolling about 3,000 participants (~2,000 with lung cancer and ~1,000 without). Blood samples are analyzed with a nitride-based Raman biochip to identify spectral patterns associated with lung cancer and its subtypes, disease stage, and clinical status. Diagnostic performance will be evaluated using sensitivity, specificity, predictive values, and ROC analyses, with exploratory analyses by histology, stage, and longitudinal status. Participants with lung cancer provide approximately 20 mL of blood annually for three years, while non-cancer participants provide a one-time sample unless they later develop cancer. The study aims to complement current imaging and pathology with a noninvasive biomarker approach to support clinical assessment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Lung Cancer Group:

  1. Age 18 years or older.
  2. Underwent low-dose computed tomography or chest computed tomography within the previous 2 years.
  3. Pathologically confirmed lung cancer.
  4. Histological diagnosis of adenocarcinoma, squamous cell carcinoma, or small cell lung cancer, with TNM stage determined by a thoracic physician.
  5. Willing to provide approximately 20 mL of peripheral blood annually for 3 years.
  6. Able to understand the study information and provide written informed consent.
  7. Agrees to linkage of study data with relevant health insurance and mortality databases, as applicable.

Non-Lung Cancer Group:

1. Age 18 years or older.
2. Underwent low-dose computed tomography or chest computed tomography within the previous 2 years.
3. No pulmonary nodule or ground-glass lesion, or a pulmonary nodule or ground-glass lesion smaller than 0.4 cm.
4. May have a chronic pulmonary disease, including chronic obstructive pulmonary disease, asthma, bronchiectasis, or pulmonary fibrosis.
5. Willing to provide one peripheral blood sample of approximately 20 mL.
6. Able to understand the study information and provide written informed consent.
7. Agrees to linkage of study data with relevant health insurance and mortality databases, as applicable.

Exclusion Criteria:

* 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.

Where it's running

• Taichung Veterans General Hospital
  Taichung, Taiwan Recruiting

Study contacts

• Study coordinator: Crc, Msc
• Email: yetquen@gmail.com
• Phone: 886 4-23592525 #6535

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.