Diagnostic and Monitoring Significance of ctDNA Methylation Analysis by NGS in Benign and Malignant Pulmonary Nodules

Pulmonary Nodules Clinical Trial

Official title:

Diagnostic and Monitoring Significance of Circulating Tumor DNA (ctDNA) Methylation Analysis by Next-Generation Sequencing in Benign and Malignant Pulmonary Nodules

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03651986
• Other study ID #: AnchorDx LC201801
• Status: Active, not recruiting
• Start date: November 26, 2018
• Est. completion date: June 2025

Study information

• Verified date: May 2023
• Source: AnchorDx Medical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 10560
• Est. completion date: June 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Pulmonary Nodules

Intervention

Diagnostic Test:
• 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)

Locations

Country	Name	City	State
China	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

Sponsors (28)

Lead Sponsor

Collaborator

AnchorDx Medical Co., Ltd.

Beijing Chao Yang Hospital, First Affiliated Hospital Xi'an Jiaotong University, First Affiliated Hospital, Sun Yat-Sen University, First Hospital of China Medical University, Guizhou Provincial People's Hospital, Henan Provincial People's Hospital, Inner Mongolia People's Hospital, LanZhou University, Peking University Third Hospital, Qilu Hospital of Shandong University, Ruijin Hospital, The Shanghai Jiao Tong University Medical School, Second Hospital of Jilin University, Shanghai Chest Hospital, Shanghai Pulmonary Hospital affiliated to Tongji University, Shanghai Zhongshan Hospital, Shantou Affiliated Hospital of Sun Yat-Sen University, Shenzhen People's Hospital, The First Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Nanchang University, The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital with Nanjing Medical University, The First People's Hospital of Yunnan, Tongji Hospital, West China Hospital, Xiamen Second Hospital, Xiangya Hospital of Central South University, Xijing Hospital, Air Force Medical University of PLA

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	3 Years