A Multicenter Clinical Trial of Sputum DNA Testing for Lung Cancer in China
NCT05337163 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1564
Last updated 2025-03-21
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).
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
- 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.
Sponsors & Collaborators
-
Guangzhou Xiangkang Medical Research Co., Ltd.
collaborator UNKNOWN -
Creative Biosciences (Guangzhou) Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Lei Zheng, PhD · Nanfang Hospital of Southern Medccal University
-
Laiyu Liu, PhD · Nanfang Hospital of Southern Medccal University
Eligibility
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-02-25
- Primary Completion
- 2025-02-18
- Completion
- 2025-03-05
Countries
- China
Study Locations
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