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

Lung Cancer Clinical Trial

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

Clinical Trial Summary

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).

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

  • Acute Bronchitis
  • Adenocarcinoma
  • Adenosquamous Carcinoma
  • Bronchitis
  • Bronchitis, Chronic
  • Carcinoma
  • Carcinoma, Adenosquamous
  • Carcinoma, Large Cell
  • Chronic Bronchitis
  • Chronic Obstructive Pulmonary Disease
  • Large Cell Carcinoma
  • Lung Cancer
  • Lung Diseases, Obstructive
  • Lung Neoplasm
  • Lung Neoplasms
  • Non-Small Cell Lung Cancer
  • Pneumonia
  • Pulmonary Disease, Chronic Obstructive
  • Pulmonary Fibrosis
  • Respiratory Tract Infection
  • Respiratory Tract Infections
  • Sarcomatoid Carcinoma
  • Small Cell Lung Cancer
  • Small Cell Lung Carcinoma
  • Squamous Cell Carcinoma
  • Tuberculosis
Clinical Trial Details
NCT number NCT05337163
Study type Observational
Source Creative Biosciences (Guangzhou) Co., Ltd.
Contact
Status Completed
Phase
Start date February 25, 2022
Completion date August 29, 2023
View Details
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