Status:
COMPLETED
A Multicenter Clinical Trial of Sputum DNA Testing for Lung Cancer in China
Lead Sponsor:
Creative Biosciences (Guangzhou) Co., Ltd.
Collaborating Sponsors:
Guangzhou Xiangkang Medical Research Co., Ltd.
Conditions:
Lung Cancer
Small Cell Lung Cancer
Eligibility:
All Genders
Brief 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 clin...
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 multipl...
Eligibility Criteria
Inclusion
- Subject must meet all three of the following criteria to be eligible for the study:
- No age or gender restrictions, voluntary participation and signing of informed consent form;
- Meet any of the following conditions:
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- Suspected of lung cancer without invasive examination;
- Diagnosed with lung cancer without surgery, radiotherapy, chemotherapy, or targeted therapy;
- 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;
- Diagnose other malignant tumors, such as thyroid cancer, esophageal cancer, liver cancer, gastric cancer, pancreatic cancer, etc.
Exclusion
- Any of the following conditions must be excluded:
- Patients who have undergone tracheotomy or have been on a ventilator due to severe illness.
- The research physician believes that other reasons are not suitable for participants in this trial.
Key Trial Info
Start Date :
February 25 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 5 2025
Estimated Enrollment :
1564 Patients enrolled
Trial Details
Trial ID
NCT05337163
Start Date
February 25 2022
End Date
March 5 2025
Last Update
March 21 2025
Active Locations (1)
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1
Nanfang Hospital of Southern Medccal University
Guangzhou, Guangdong, China