Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Multiple Pulmonary Nodules

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

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.

A blood-based assay for differentiating benign and malignant pulmonary nodules early using circulating tumor DNA (ctDNA) methylation analysis by next-generation sequencing (NGS)

ctDNA methylation analysis by NGS

Nanshan ZHONG, MD

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.

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.

Whole blood

Formalin-fixed paraffin-embedded (FFPE) tissue

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

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

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).

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).

Xiangya Hospital of Central South University

West China Hospital

Shanghai Zhongshan Hospital

Shanghai Pulmonary Hospital affiliated to Tongji University

First Hospital of China Medical University

Guizhou Provincial People's Hospital

Shanghai Chest Hospital

First Affiliated Hospital, Sun Yat-Sen University

First Affiliated Hospital Xi'an Jiaotong University

Qilu Hospital of Shandong University

Inner Mongolia People's Hospital

The First Affiliated Hospital with Nanjing Medical University

The First Affiliated Hospital of Zhengzhou University

Second Hospital of Jilin University

LanZhou University

Peking University Third Hospital

The First People's Hospital of Yunnan

Shantou Affiliated Hospital of Sun Yat-Sen University

Ruijin Hospital, The Shanghai Jiao Tong University Medical School

Tongji Hospital

The First Affiliated Hospital of Guangzhou Medical University

Xijing Hospital, Air Force Medical University of PLA

Shenzhen People's Hospital

Henan Provincial People's Hospital

Beijing Chao Yang Hospital

Xiamen Second Hospital

The First Affiliated Hospital of Nanchang University

AnchorDx Medical Co., Ltd.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Diagnostic and Monitoring Significance of ctDNA Methylation Analysis by NGS in Benign and Malignant Pulmonary Nodules	NCT03651986	Pulmonary Nodul...	ctDNA methylati...	18 Years -	AnchorDx Medical Co., Ltd.
Diagnostic and Monitoring Significance of ctDNA Methylation Analysis by NGS in Benign and Malignant Pulmonary Nodules	NCT03651986	Pulmonary Nodul...	ctDNA methylati...	18 Years -	AnchorDx Medical Co., Ltd.

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