Circulating Tumor DNA Methylation Test to Differentiate Benign and Malignant Pulmonary Nodules
- Conditions
- Pulmonary Nodule, Solitary
- Registration Number
- NCT03181490
- Lead Sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1490
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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) 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Department of Thoracic Surgery, Anhui Chest Hospital
π¨π³Hefei, China
Department of Thoracic Surgery, Beijing Cancer Hospital
π¨π³Beijing, China
Department of Thoracic Surgery, The Second Xiangya Hospital of Central South University
π¨π³Changsha, China
Department of Thoracic Surgery, Xuanwu Hospital, Capital Medical University
π¨π³Beijing, China
Department of Thoracic Surgery, Xiangya Hospital, Central South University
π¨π³Changsha, China
Department of Thoracic Surgery, The First Affiliated Hospital of Guangzhou Medical University
π¨π³Guangzhou, China
Department of Thoracic Surgery, The Forth Affiliated Hospital of Harbin Medical University
π¨π³Haerbin, China
Department of Thoracic Surgery, West China Hospital of Sichuan University
π¨π³Chengdu, China
Department of Thoracic Surgery, The First Affiliated Hospital of Sun Yat-sen University
π¨π³Guangzhou, China
Department of Thoracic Surgery, Nanfang Hospital of Southern Medical University
π¨π³Guangzhou, China
Department of Thoracic Surgery, Qilu Hospital of Shandong University
π¨π³Jinan, China
Department of Thoracic Surgery, The Second HospitalοΌUniversity of South China
π¨π³Hengyang, China
Department of Thoracic Surgery, Shenzhen People's Hospital
π¨π³Shenzhen, China
Department of Thoracic Surgery, Jiangsu Province Hospital
π¨π³Nanjing, China