Pulmonary Nodules Clinical Trial
Official title:
Diagnostic and Monitoring Significance of Circulating Tumor DNA (ctDNA) Methylation Analysis by Next-Generation Sequencing in Benign and Malignant Pulmonary Nodules
Verified date | May 2023 |
Source | AnchorDx Medical Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 10560 |
Est. completion date | June 2025 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 Years and older - pulmonary nodules diagnosed by chest CT or low-dose computed tomography (LDCT) scans - non-calcified pulmonary nodules with the diameter between 5mm to 30mm - including solid nodules, mixed ground-glass opacity nodules and pure ground-glass opacity lung modules - new cases of pulmonary nodules or diagnosed within 60 days prior to enrollment - agree to finish the Patient Pulmonary History Questionnaire - agree to be followed up for 2-3 years - agree to provide a written informed consent Exclusion Criteria: - pregnant or lactating women - received any pneumonectomy or percutaneous lung biopsy before enrollment - recipients of blood transfusions within 30 days prior to enrollment - patients with tumors identified within 2 years prior to enrollment except non-melanoma skin cancer - fail to understand or provide a written informed consent |
Country | Name | City | State |
---|---|---|---|
China | 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 |
Lead Sponsor | Collaborator |
---|---|
AnchorDx Medical Co., Ltd. | Beijing Chao Yang Hospital, First Affiliated Hospital Xi'an Jiaotong University, First Affiliated Hospital, Sun Yat-Sen University, First Hospital of China Medical University, Guizhou Provincial People's Hospital, Henan Provincial People's Hospital, Inner Mongolia People's Hospital, LanZhou University, Peking University Third Hospital, Qilu Hospital of Shandong University, Ruijin Hospital, The Shanghai Jiao Tong University Medical School, Second Hospital of Jilin University, Shanghai Chest Hospital, Shanghai Pulmonary Hospital affiliated to Tongji University, Shanghai Zhongshan Hospital, Shantou Affiliated Hospital of Sun Yat-Sen University, Shenzhen People's Hospital, The First Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Nanchang University, The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital with Nanjing Medical University, The First People's Hospital of Yunnan, Tongji Hospital, West China Hospital, Xiamen Second Hospital, Xiangya Hospital of Central South University, Xijing Hospital, Air Force Medical University of PLA |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The diagnostic performance of the blood-based assay for differentiating benign and malignant pulmonary nodules early using circulating tumor DNA (ctDNA) methylation analysis by next-generation sequencing (NGS) | The efficacy of the blood-based ctDNA methylation assay comparing with pathologic diagnosis, the gold standard, and CT/LDCT diagnosis, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV). | 3 Years | |
Secondary | The diagnostic and monitoring significance of routine tests integrating with ctDNA methylation analysis by NGS in differentiating benign and malignant pulmonary nodules | The diagnostic performance of the combination of routine tests and ctDNA methylation analysis by NGS in differentiating benign and malignant pulmonary nodules, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV). | 3 Years |
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