A Multicenter Clinical Trial of Sputum DNA Testing for Lung Cancer in China

A Multicenter, Single-blind, Pair-matched, Observational Clinical Trial of LUNSAFE

The primary objective of this study is to assess the safety and effectiveness of Human Multigene Methylation Detection Kit (Fluorescent PCR Method) for help diagnose lung cancer by comparing with clinical standard method (includes chest CT examination or pathological examination).

In this clinical trial, the testing kit to be evaluated is a Human Multigene Methylation Detection Kit (Fluorescent PCR Method), which is intended to qualitatively detect methylation levels of multiple genes in human sputum specimen in vitro by Fluorescent PCR Method, and the standard method used in clinical diagnosis is chest CT examination or pathological examination.

Subjects will provided sputum specimen as required for the evaluation of the testing kit followed by a chest CT examination or pathological examination. Technical personnel who conduct the evaluation of the testing kit will remain blinded to the results of the clinical diagnosis by chest CT and/or pathological examination.

The results of the testing kit will be compared with the standard method, and the effectiveness of the Human Multigene Methylation Detection Kit (Fluorescent PCR Method) for lung cancer detection under normal clinical use will be assessed through statistical analysis.

Inclusion Criteria:

• Subject must meet all three of the following criteria to be eligible for the study:

  1. No age or gender restrictions, voluntary participation and signing of informed consent form;
  2. Meet any of the following conditions:
  1. Suspected of lung cancer without invasive examination;
  2. Diagnosed with lung cancer without surgery, radiotherapy, chemotherapy, or targeted therapy;
  3. Diagnose other respiratory diseases, such as pulmonary infections (bacterial pneumonia, mycoplasma pneumonia, chlamydia pneumonia, viral pneumonia, lung abscess, etc.), interstitial lung diseases (pulmonary fibrosis, pulmonary granulomas, etc.), benign pulmonary nodules, tuberculosis, emphysema, pulmonary cysts, benign pulmonary tumors, obstructive pulmonary disease, bronchial infections/asthma, acute upper respiratory tract infections, etc;
  4. Diagnose other malignant tumors, such as thyroid cancer, esophageal cancer, liver cancer, gastric cancer, pancreatic cancer, etc.

Exclusion Criteria:

• Any of the following conditions must be excluded:

  1. Patients who have undergone tracheotomy or have been on a ventilator due to severe illness.
  2. The research physician believes that other reasons are not suitable for participants in this trial.