Diagnostic and Monitoring Significance of ctDNA Methylation Analysis by NGS in Benign and Malignant Pulmonary Nodules
- Conditions
- Pulmonary Nodules
- Interventions
- Diagnostic Test: ctDNA methylation analysis by NGS
- Registration Number
- NCT03651986
- Lead Sponsor
- AnchorDx Medical Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 10560
-
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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Prospective Cohort ctDNA methylation analysis by NGS This is a prospectively enrolling cohort study and a stratified case-cohort design will be employed to select malignant pulmonary nodules cases and benign pulmonary nodules subjects who will be assayed. All participants will be followed up with chest CT or low-dose computed tomography (LDCT) scans for 2-3 years, and take the diagnostic test, ctDNA methylation analysis by NGS, at each visit.
- Primary Outcome Measures
Name Time Method 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) 3 Years 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).
- Secondary Outcome Measures
Name Time Method The diagnostic and monitoring significance of routine tests integrating with ctDNA methylation analysis by NGS in differentiating benign and malignant pulmonary nodules 3 Years 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).
Trial Locations
- Locations (23)
Department of Pulmonary Medicine, The First Affiliated Hospital of Sun Yat-Sen University
🇨🇳Guangzhou, China
Department of Pulmonary and Critical Care Medicine, Inner Mongolia Autonomous Region People's Hospital
🇨🇳Hohhot, China
Department of Pulmonary & Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong 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, QILU Hospital, Shandong University
🇨🇳Jinan, 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 and Critical Care Medicine, Beijing Chaoyang Hospital
🇨🇳Beijing, China
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, China
Department of Respiratory Medicine, Shenzhen People's Hospital
🇨🇳Shenzhen, China
Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital, Xi'an Jiaotong University
🇨🇳Xi'an, China
Department of Respiratory Medicine, Henan Provincial People's Hospital
🇨🇳Zhengzhou, China
Xiangya Hospital of Central South University
🇨🇳Changsha, China
Department of Respiratory Medicine, West China Hospital of Sichuan University
🇨🇳Chengdu, 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 Pulmonary Medicine, Xijing Hospital, Air Force Medical University of PLA
🇨🇳Xi'an, China
Department of Respiration, The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, China
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, China
Department of Cardiothoracic Surgery, The Second Affiliated Hospital of Xiamen Medical College
🇨🇳Xiamen, China
Department of Respiration and Critical Care Medicine, Guizhou Provincial People's Hospital
🇨🇳Guiyang, China