Clinical trial NCT03651986: Diagnostic and Monitoring Significance of ctDNA Methylation Analysis by NGS in Benign and Malignant Pulmonary Nodules
Official title: Diagnostic and Monitoring Significance of Circulating Tumor DNA (ctDNA) Methylation Analysis by Next-Generation Sequencing in Benign and Malignant Pulmonary Nodules
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Nodules
Keywords: Circulating Tumor DNA (ctDNA)
DNA Methylation Analysis
Next-Generation Sequencing (NGS)
Low-Dose Computed Tomography (LDCT)
Lead sponsor: AnchorDx Medical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Xiangya Hospital of Central South University
name: West China Hospital
name: Shanghai Zhongshan Hospital
name: Shanghai Pulmonary Hospital affiliated to Tongji University
name: First Hospital of China Medical University
name: Guizhou Provincial People's Hospital
name: Shanghai Chest Hospital
name: First Affiliated Hospital, Sun Yat-Sen University
name: First Affiliated Hospital Xi'an Jiaotong University
name: Qilu Hospital of Shandong University
name: Inner Mongolia People's Hospital
name: The First Affiliated Hospital with Nanjing Medical University
name: The First Affiliated Hospital of Zhengzhou University
name: Second Hospital of Jilin University
name: LanZhou University
name: Peking University Third Hospital
name: The First People's Hospital of Yunnan
name: Shantou Affiliated Hospital of Sun Yat-Sen University
name: Ruijin Hospital
name: Tongji Hospital
name: The First Affiliated Hospital of Guangzhou Medical University
name: The First Affiliated Hospital of Air Force Medicial University
name: Shenzhen People's Hospital
name: Henan Provincial People's Hospital
name: Beijing Chao Yang Hospital
name: Xiamen Second Hospital
name: The First Affiliated Hospital of Nanchang University
First posted: 2018-08-29
Enrollment: 10560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with pulmonary nodules diagnosed by chest CT or low-dose computed tomography (LDCT) scans

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 3 Years
Secondary outcomes:
measure: The diagnostic and monitoring significance of routine tests integrating with ctDNA methylation analysis by NGS in differentiating benign and malignant pulmonary nodules
timeFrame: 3 Years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Respiratory and Critical Care Medicine, Beijing Chaoyang Hospital
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
city: Chengdu
country: China
facility: Department of Respiratory Medicine, West China Hospital of Sichuan University
city: Guangzhou
country: China
facility: Department of Pulmonary Medicine, The First Affiliated Hospital of Sun Yat-Sen University
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
city: Guiyang
country: China
facility: Department of Respiration and Critical Care Medicine, Guizhou Provincial People's Hospital
city: Hohhot
country: China
facility: Department of Pulmonary and Critical Care Medicine, Inner Mongolia Autonomous Region People's Hospital
city: Jinan
country: China
facility: Department of Respiratory, QILU Hospital, Shandong University
city: Kunming
country: China
facility: Department of Respiratory Medicine, The First People's Hospital of Yunnan Province
city: Lanzhou
country: China
facility: Department of Gerontal Respiratory Medicine, The Frist Hospital of Lanzhou University
city: Nanchang
country: China
facility: Department of Respiration, The First Affiliated Hospital of Nanchang University
city: Shanghai
country: China
facility: Department of Pulmonary & Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiaotong University
city: Shanghai
country: China
facility: Department of Pulmonary Medicine, Zhongshan Hospital, Fudan University
city: Shanghai
country: China
facility: Department of Respiratory Medicine, Shanghai Pulmonary Hospital, Tongji University School of Medicine
city: Shantou
country: China
facility: Department of Respiratory Medicine, Shantou Central Hospital
city: Shenyang
country: China
facility: Department of Respiratory Medicine, The First Hospital of China Medical University
city: Shenzhen
country: China
facility: Department of Respiratory Medicine, Shenzhen People's Hospital
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
city: Xi'an
country: China
facility: Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital, Xi'an Jiaotong University
city: Xi'an
country: China
facility: Department of Pulmonary Medicine, Xijing Hospital, Air Force Medical University of PLA
city: Xiamen
country: China
facility: Department of Cardiothoracic Surgery, The Second Affiliated Hospital of Xiamen Medical College
city: Zhengzhou
country: China
facility: Department of Respiratory Medicine, Henan Provincial People's Hospital
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Nanshan ZHONG, MD
role: STUDY_CHAIR
References:
citation: 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.