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.
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.
Study Type
OBSERVATIONAL
Enrollment
10,560
A blood-based assay for differentiating benign and malignant pulmonary nodules early using circulating tumor DNA (ctDNA) methylation analysis by next-generation sequencing (NGS)
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).
Time frame: 3 Years
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).
Time frame: 3 Years
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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
...and 13 more locations