Clinical trial NCT03181490: Circulating Tumor DNA Methylation Test to Differentiate Benign and Malignant Pulmonary Nodules
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Nodule, Solitary
Keywords: Pulmonary Nodule
Solitary
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
Collaborators: name: AnchorDx Medical Co., Ltd.
name: First Affiliated Hospital, Sun Yat-Sen University
name: Nanfang Hospital, Southern Medical University
name: Central South University
name: Xiangya Hospital of Central South University
name: West China Hospital
name: Qilu Hospital of Shandong University
name: The Second Hospital University of South China
name: Shenzhen People's Hospital
name: The Fourth Affiliated Hospital of Harbin Medical University
name: Peking University Cancer Hospital & Institute
name: Xuanwu Hospital, Beijing
name: Anhui Chest Hospital
name: The First Affiliated Hospital with Nanjing Medical University
First posted: 2017-06-08
Enrollment: 1490
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Pre-surgery adult patients with single pulmonary nodule found by CT scan.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Thoracic Surgery, Beijing Cancer Hospital
city: Beijing
country: China
facility: Department of Thoracic Surgery, Xuanwu Hospital, Capital Medical University
city: Changsha
country: China
facility: Department of Thoracic Surgery, The Second Xiangya Hospital of Central South University
city: Changsha
country: China
facility: Department of Thoracic Surgery, Xiangya Hospital, Central South University
city: Chengdu
country: China
facility: Department of Thoracic Surgery, West China Hospital of Sichuan University
city: Guangzhou
country: China
facility: Department of Thoracic Surgery, Nanfang Hospital of Southern Medical University
city: Guangzhou
country: China
facility: Department of Thoracic Surgery, The First Affiliated Hospital of Guangzhou Medical University
city: Guangzhou
country: China
facility: Department of Thoracic Surgery, The First Affiliated Hospital of Sun Yat-sen University
city: Haerbin
country: China
facility: Department of Thoracic Surgery, The Forth Affiliated Hospital of Harbin Medical University
city: Hefei
country: China
facility: Department of Thoracic Surgery, Anhui Chest Hospital
city: Hengyang
country: China
facility: Department of Thoracic Surgery, The Second Hospital，University of South China
city: Jinan
country: China
facility: Department of Thoracic Surgery, Qilu Hospital of Shandong University
city: Nanjing
country: China
facility: Department of Thoracic Surgery, Jiangsu Province Hospital
city: Shenzhen
country: China
facility: Department of Thoracic Surgery, Shenzhen People's Hospital
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Jianxing He, MD
role: PRINCIPAL_INVESTIGATOR
References: