Diagnostic and Monitoring Significance of ctDNA Methylation Analysis by NGS in Benign and Malignant Pulmonary Nodules
1 other identifier
observational
10,560
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2018
Longer than P75 for all trials
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2018
CompletedFirst Posted
Study publicly available on registry
August 29, 2018
CompletedStudy Start
First participant enrolled
November 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedMay 24, 2023
May 1, 2023
5.8 years
August 27, 2018
May 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
The diagnostic and monitoring significance of routine tests integrating with ctDNA methylation analysis by NGS in differentiating benign and malignant pulmonary nodules
3 Years
Study Arms (1)
Prospective Cohort
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.
Interventions
A blood-based assay for differentiating benign and malignant pulmonary nodules early using circulating tumor DNA (ctDNA) methylation analysis by next-generation sequencing (NGS)
Eligibility Criteria
Subjects with pulmonary nodules diagnosed by chest CT or low-dose computed tomography (LDCT) scans
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AnchorDx Medical Co., Ltd.lead
- Xiangya Hospital of Central South Universitycollaborator
- West China Hospitalcollaborator
- Shanghai Zhongshan Hospitalcollaborator
- Shanghai Pulmonary Hospital affiliated to Tongji Universitycollaborator
- First Hospital of China Medical Universitycollaborator
- Guizhou Provincial People's Hospitalcollaborator
- Shanghai Chest Hospitalcollaborator
- First Affiliated Hospital, Sun Yat-Sen Universitycollaborator
- First Affiliated Hospital Xi'an Jiaotong Universitycollaborator
- Qilu Hospital of Shandong Universitycollaborator
- Inner Mongolia People's Hospitalcollaborator
- The First Affiliated Hospital with Nanjing Medical Universitycollaborator
- The First Affiliated Hospital of Zhengzhou Universitycollaborator
- Second Hospital of Jilin Universitycollaborator
- LanZhou Universitycollaborator
- Peking University Third Hospitalcollaborator
- The First People's Hospital of Yunnancollaborator
- Shantou Affiliated Hospital of Sun Yat-Sen Universitycollaborator
- Ruijin Hospitalcollaborator
- Tongji Hospitalcollaborator
- The First Affiliated Hospital of Guangzhou Medical Universitycollaborator
- The First Affiliated Hospital of Air Force Medicial Universitycollaborator
- Shenzhen People's Hospitalcollaborator
- Henan Provincial People's Hospitalcollaborator
- Beijing Chao Yang Hospitalcollaborator
- Xiamen Second Hospitalcollaborator
- The First Affiliated Hospital of Nanchang Universitycollaborator
Study Sites (23)
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
Related Publications (1)
Liang W, Liu D, Li M, Wang W, Qin Z, Zhang J, Zhang Y, Hu Y, Bao H, Xiang Y, Wang B, Wu J, Sun J, Hu C, Ye X, Zhang X, Xiao W, Yun C, Sun D, Wang W, Chang N, Zhang Y, Zhao J, Zhang X, Xu J, Wu D, Liu X, Guo Y, Zhang Q, Zhang W, Yang L, Li Z, Zhang X, Han B, Tong Z, He J, Qu J, Fan JB, Zhong N. Evaluating the diagnostic accuracy of a ctDNA methylation classifier for incidental lung nodules: protocol for a prospective, observational, and multicenter clinical trial of 10,560 cases. Transl Lung Cancer Res. 2020 Oct;9(5):2016-2026. doi: 10.21037/tlcr-20-701.
PMID: 33209621DERIVED
Biospecimen
Whole blood Formalin-fixed paraffin-embedded (FFPE) tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Nanshan ZHONG, MD
The First Affiliated Hospital of Guangzhou Medical University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2018
First Posted
August 29, 2018
Study Start
November 26, 2018
Primary Completion
September 1, 2024
Study Completion
June 1, 2025
Last Updated
May 24, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share