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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pulmonary Nodule, Solitary Lung Diseases Respiratory Tract Diseases Solitary Pulmonary Nodule

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Thoracic Surgery, Beijing Cancer Hospital, Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Circulating Tumor DNA Methylation Test

Diagnostic Test

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

Primary outcomes

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)

Time frame: 1 year

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).

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University

Other

Collaborators

AnchorDx Medical Co., Ltd.
Anhui Chest Hospital
Central South University
First Affiliated Hospital, Sun Yat-Sen University
Nanfang Hospital, Southern Medical University
Peking University Cancer Hospital & Institute
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

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Jun 8, 2017
Registry last updated: Apr 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed