Spots Global Cancer Trial Database for Diagnostic and Monitoring Significance of ctDNA Methylation Analysis by NGS in Benign and Malignant Pulmonary Nodules
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Trial Identification
Brief Title: Diagnostic and Monitoring Significance of ctDNA Methylation Analysis by NGS in Benign and Malignant Pulmonary Nodules
Official Title: Diagnostic and Monitoring Significance of Circulating Tumor DNA (ctDNA) Methylation Analysis by Next-Generation Sequencing in Benign and Malignant Pulmonary Nodules
Study ID: NCT03651986
Conditions
Interventions
Study Description
Brief Summary: AnchorDx is using circulating tumor DNA (ctDNA) methylation analysis by next-generation sequencing (NGS) to develop a blood-based assay for differentiating benign and malignant pulmonary nodules early. The purpose of this study is to evaluate the diagnostic performance of this assay in patients with pulmonary nodules.
Detailed Description: This is a prospective, multi-center, observational cohort study and seeks to enroll 10,560 participants with pulmonary nodules smaller than 3 cm in diameter from 21 hospitals in China. All participants will be followed up with chest CT or low-dose computed tomography (LDCT) scans for 2-3 years ( baseline, 3 months, 6 months, 12 months, 24 months and 36 months). Their blood samples, CT or LDCT scans data, and clinical data will be collected at each visit and Formalin-fixed paraffin-embedded (FFPE) tissues will be collected when participants who receive pneumonectomy or percutaneous lung biopsy.
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
Xiangya Hospital of Central South University, Changsha, , China
Department of Respiratory Medicine, West China Hospital of Sichuan University, Chengdu, , China
Department of Pulmonary Medicine, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, , China
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, , China
Department of Respiration and Critical Care Medicine, Guizhou Provincial People's Hospital, Guiyang, , China
Department of Pulmonary and Critical Care Medicine, Inner Mongolia Autonomous Region People's Hospital, Hohhot, , China
Department of Respiratory, QILU Hospital, Shandong University, Jinan, , China
Department of Respiratory Medicine, The First People's Hospital of Yunnan Province, Kunming, , China
Department of Gerontal Respiratory Medicine, The Frist Hospital of Lanzhou University, Lanzhou, , China
Department of Respiration, The First Affiliated Hospital of Nanchang University, Nanchang, , China
Department of Pulmonary & Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, , China
Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, , China
Department of Pulmonary Medicine, Zhongshan Hospital, Fudan University, Shanghai, , China
Department of Respiratory Medicine, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, , China
Department of Respiratory Medicine, Shantou Central Hospital, Shantou, , China
Department of Respiratory Medicine, The First Hospital of China Medical University, Shenyang, , China
Department of Respiratory Medicine, Shenzhen People's Hospital, Shenzhen, , China
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, , China
Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital, Xi'an Jiaotong University, Xi'an, , China
Department of Pulmonary Medicine, Xijing Hospital, Air Force Medical University of PLA, Xi'an, , China
Department of Cardiothoracic Surgery, The Second Affiliated Hospital of Xiamen Medical College, Xiamen, , China
Department of Respiratory Medicine, Henan Provincial People's Hospital, Zhengzhou, , China
Contact Details
Name: Nanshan ZHONG, MD
Affiliation: The First Affiliated Hospital of Guangzhou Medical University
Role: STUDY_CHAIR
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