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

Pulmonary Nodule, Solitary Clinical Trial

Official title:

Multi-centers Validation of a Circulating Tumor DNA Assay to Differentiate Benign and Malignant Pulmonary Nodules Via Targeted High-throughput DNA Methylation Sequencing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03181490
• Other study ID #: CCTC1701
• Status: Completed
• Start date: June 8, 2017
• Est. completion date: May 31, 2019

Study information

• Verified date: March 2020
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This is a prospective, multi-center, observational cohort study and seeks to enroll 1230 participants with pulmonary nodules 5-30mm in diameter.

The assay analyzes the ctDNA methylation profiles of lung cancer-specific biomarkers non-invasively using whole blood specimens collected before invasive surgery.

The performance characteristics(sensitivity and specificity) of the pre-surgery ctDNA methylation test for detection of early lung cancer is evaluated in comparison to post-surgery pathology.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1490
• Est. completion date: May 31, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years old or above

• single pulmonary nodule found by CT scan.

• the diameter of the pulmonary nodule is between 5mm to 30mm.

• plan to accept pneumonectomy due to the pulmonary nodule.

• without any sign of lymphatic or distant metastasis.

• agree to sign informed consent.

Exclusion Criteria:

• pregnant or lactating women.

• the diameter of the pulmonary nodule is more than 30mm

• there are 2 or more pulmonary nodules in one single patient.

• any sign of lymphatic or distant metastasis

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Pulmonary Nodule, Solitary
• Solitary Pulmonary Nodule

Intervention

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

Locations

Country	Name	City	State
China	Department of Thoracic Surgery, Beijing Cancer Hospital	Beijing
China	Department of Thoracic Surgery, Xuanwu Hospital, Capital Medical University	Beijing
China	Department of Thoracic Surgery, The Second Xiangya Hospital of Central South University	Changsha
China	Department of Thoracic Surgery, Xiangya Hospital, Central South University	Changsha
China	Department of Thoracic Surgery, West China Hospital of Sichuan University	Chengdu
China	Department of Thoracic Surgery, Nanfang Hospital of Southern Medical University	Guangzhou
China	Department of Thoracic Surgery, The First Affiliated Hospital of Guangzhou Medical University	Guangzhou
China	Department of Thoracic Surgery, The First Affiliated Hospital of Sun Yat-sen University	Guangzhou
China	Department of Thoracic Surgery, The Forth Affiliated Hospital of Harbin Medical University	Haerbin
China	Department of Thoracic Surgery, Anhui Chest Hospital	Hefei
China	Department of Thoracic Surgery, The Second Hospital,University of South China	Hengyang
China	Department of Thoracic Surgery, Qilu Hospital of Shandong University	Jinan
China	Department of Thoracic Surgery, Jiangsu Province Hospital	Nanjing
China	Department of Thoracic Surgery, Shenzhen People's Hospital	Shenzhen

Sponsors (15)

Lead Sponsor

Collaborator

The First Affiliated Hospital of Guangzhou Medical University

AnchorDx Medical Co., Ltd., Anhui Chest Hospital, Beijing Cancer Hospital, Central South University, First Affiliated Hospital, Sun Yat-Sen University, Nanfang Hospital of Southern Medical University, Qilu Hospital of Shandong University, Shenzhen People's Hospital, The First Affiliated Hospital with Nanjing Medical University, The Fourth Affiliated Hospital of Harbin Medical University, The Second Hospital University of South China, West China Hospital, Xiangya Hospital of Central South University, Xuanwu Hospital, Beijing

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, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).	1 year