Spots Global Cancer Trial Database for A Prospective Cohort Study of Chinese Patients With Pulmonary Nodules: Prediction of Lung Cancer Using Noninvasive Biomarkers
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Trial Identification
Brief Title: A Prospective Cohort Study of Chinese Patients With Pulmonary Nodules: Prediction of Lung Cancer Using Noninvasive Biomarkers
Official Title: A Prospective Cohort Study of Chinese Patients With Pulmonary Nodules: Prediction of Lung Cancer Using Noninvasive Biomarkers
Study ID: NCT04462185
Conditions
Interventions
Study Description
Brief Summary: The broad goals of this study is to identify changes in genomic landscape during transition from stage 0 to stage 1 lung cancer. This study intends to determine whether diagnostic biomarkers measured in minimally invasive biospecimens are able to correlate molecular, clinical and imaging features to distinguish malignant from benign pulmonary nodules. The diagnostic markers once validated can be used as broad screening tools for lung cancer.
Detailed Description: The four-year study aims to recruit 3000 patients (1500 GGO and 1500 solid / semi solid nodules) in the study based on qualifying for a lung cancer screening CT or by routine CT chest with the observation of a lung nodule between 5-30mm diameter. These patients will be followed for 2\~3 years and be managed according to institutional standard of care. This may involve the Chinese Thoracic Society guideline or Fleischner criteria (either 2013 or 2017 guidelines). The clinical data, CT imaging and biospecimens will be collected during each visit. Once a patient undergoes surgery, tissue samples (FFPE) from surgery will also be collected. The gold standard for lung cancer diagnosis will be the results of bronchoscopic biopsy of lung or lymph nodes, percutaneous biopsy of lung or other organ sites, surgical biopsy or resection, or a minimum follow-up of 2 years.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
Department of Respiratory and Critical Care Medicine, Beijing Chaoyang Hospital, Beijing, , China
Department of Respiratory Medicine, West China Hospital of Sichuan University, Chengdu, , China
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, , China
Department of Respiratory, Qilu Hospital, Shandong University, Jinan, , China
Department of Pulmonary Medicine, Zhongshan Hospital, Fudan University, Shanghai, , China
Department of Respiratory and Critical Care Medicine, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, , China
Contact Details
Name: Nanshan ZHONG, MD
Affiliation: The First Affiliated Hospital of Guangzhou Medical University
Role: STUDY_CHAIR
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