Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| AnchorDx Medical Co., Ltd. | INDUSTRY |
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Nanfang Hospital, Southern Medical University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Pre-surgery adult patients with single pulmonary nodule found by CT scan.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jianxing He, MD | The First Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Thoracic Surgery, Beijing Cancer Hospital | Beijing | China | ||||
| Department of Thoracic Surgery, Xuanwu Hospital, Capital Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41831027 | Derived | Zeng F, Wang B, Peng M, Tao J, Tu X, Lu H, Qiu X, Yang Y, Wang W, Zeng M, Fan JB, Zeng Q, Liu Q. Comparison of clinical-radiological and radiomics features for predicting pulmonary nodule malignancy in a multicenter study of mixed clinical and surveillance populations. Eur Radiol. 2026 Jul;36(7):6179-6192. doi: 10.1007/s00330-026-12437-3. Epub 2026 Mar 14. |
Not provided
Not provided
Not provided
| Central South University |
| OTHER |
| Xiangya Hospital of Central South University | OTHER |
| West China Hospital | OTHER |
| Qilu Hospital of Shandong University | OTHER |
| The Second Hospital University of South China | OTHER |
| Shenzhen People's Hospital | OTHER |
| The Fourth Affiliated Hospital of Harbin Medical University | OTHER |
| Peking University Cancer Hospital & Institute | OTHER |
| Xuanwu Hospital, Beijing | OTHER |
| Anhui Chest Hospital | OTHER |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
Not provided
Not provided
Not provided
whole blood
| 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 | China |
| ID | Term |
|---|---|
| D003074 | Solitary Pulmonary Nodule |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided