Diagnostic and Monitoring Significance of ctDNA Methylation Analysis by NGS in Benign and Malignant Pulmonary Nodules
NCT ID: NCT03651986
Last Updated: 2023-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
10560 participants
OBSERVATIONAL
2018-11-26
2025-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Circulating Tumor DNA Methylation Test to Differentiate Benign and Malignant Pulmonary Nodules
NCT03181490
Non-Invasive ctDNA Methylation Detection for Lung Nodule Patients
NCT03685669
A Prospective Cohort Study of Chinese Patients With Pulmonary Nodules: Prediction of Lung Cancer Using Noninvasive Biomarkers
NCT04462185
Methylation of cfDNA in Diagnosing and Monitoring Pulmonary Nodule
NCT03989219
Predicting Non-small Cell Lung Cancer (NSCLC) Lymph Node Metastasis: Integrating Circulating Tumor DNA (ctDNA) Mutation/ Methylation Profiling With Positron Emission Tomography-computed Tomography (PET-CT) Scan
NCT06358222
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
ctDNA methylation analysis by NGS
A blood-based assay for differentiating benign and malignant pulmonary nodules early using circulating tumor DNA (ctDNA) methylation analysis by next-generation sequencing (NGS)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ctDNA methylation analysis by NGS
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Xiangya Hospital of Central South University
OTHER
West China Hospital
OTHER
Shanghai Zhongshan Hospital
OTHER
Shanghai Pulmonary Hospital affiliated to Tongji University
UNKNOWN
First Hospital of China Medical University
OTHER
Guizhou Provincial People's Hospital
OTHER
Shanghai Chest Hospital
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Qilu Hospital of Shandong University
OTHER
Inner Mongolia People's Hospital
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
Second Hospital of Jilin University
OTHER
LanZhou University
OTHER
Peking University Third Hospital
OTHER
The First People's Hospital of Yunnan
OTHER
Shantou Affiliated Hospital of Sun Yat-Sen University
UNKNOWN
Ruijin Hospital
OTHER
Tongji Hospital
OTHER
The First Affiliated Hospital of Guangzhou Medical University
OTHER
The First Affiliated Hospital of Air Force Medicial University
OTHER
Shenzhen People's Hospital
OTHER
Henan Provincial People's Hospital
OTHER
Beijing Chao Yang Hospital
OTHER
Xiamen Second Hospital
UNKNOWN
The First Affiliated Hospital of Nanchang University
OTHER
AnchorDx Medical Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nanshan ZHONG, MD
Role: STUDY_CHAIR
The First Affiliated Hospital of Guangzhou Medical University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AnchorDx LC201801
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.