NCT05337163

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,564 (actual)
• Sponsor: Creative Biosciences (Guangzhou) Co., Ltd. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Lung Cancer
• Small Cell Lung Cancer
• Non-Small Cell Lung Cancer
• Squamous Cell Carcinoma
• Adenocarcinoma
• Large Cell Carcinoma
• Adenosquamous Carcinoma
• Sarcomatoid Carcinoma
• Respiratory Tract Infection
• Acute Bronchitis
• Pneumonia
• Chronic Bronchitis
• Chronic Obstructive Pulmonary Disease
• Tuberculosis
• Lung Neoplasm
• Pulmonary Interstitial Fibrosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Diagnostic Test: Sputum DNA methylation analysis	Diagnostic Test: sputum specimen will be collected by the subject for the detection of Human Multigene Methylation Detection Kit (Fluorescent PCR Method)
PROCEDURE	chest CT or pathological examination	Subjects will undergo chest CT or pathological examination.

Timeline

• Start date: 2022-02-25
• Primary completion: 2025-02-18
• Completion: 2025-03-05
• First posted: 2022-04-20
• Last updated: 2025-03-21

Locations

1 site across 1 country: China