Circulating Tumor DNA Methylation Test to Differentiate Benign and Malignant Pulmonary Nodules

Summary

Current state-of-the-art lung cancer early screening utilizes low-dose CT scan to identify lung nodules smaller than 3 cm in diameter. However, it's still a clinical challenge to differentiate between malignant and benign nodules.

In previous studies, the investigators had taken the approach of methylation profiling by high throughput bisulfite DNA sequencing in tissue samples to identify specific methylation signatures. The investigators had learned methylation patterns that differentiate malignant vs. benign lesions from tissue samples by in-depth data mining, and then used pattern matching to classify plasma samples.

In this study, the investigators are going to validate the efficacy of ctDNA methylation test for diagnosing early lung cancer by comparing results of the pre-surgery ctDNA methylation test with the post-surgery pathology.

Conditions

• Pulmonary Nodule, Solitary

Interventions

DIAGNOSTIC_TEST

Circulating Tumor DNA Methylation Test

Methylation profiling by high-throughput bisulfite DNA sequencing in blood sample to differentiate benign and malignant pulmonary nodules

Sponsors & Collaborators

• AnchorDx Medical Co., Ltd.

  collaborator INDUSTRY

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• Central South University

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• The Second Hospital University of South China

  collaborator OTHER

• Shenzhen People's Hospital

  collaborator OTHER

• The Fourth Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• Peking University Cancer Hospital & Institute

  collaborator OTHER

• Xuanwu Hospital, Beijing

  collaborator OTHER

• Anhui Chest Hospital

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• The First Affiliated Hospital of Guangzhou Medical University

  lead OTHER

Principal Investigators

• Jianxing He, MD · The First Affiliated Hospital of Guangzhou Medical University

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-06-08

Primary Completion

2019-02-28

Completion

2019-05-31

Countries

• China

Study Locations