Circulating Tumor DNA Methylation Test to Differentiate Benign and Malignant Pulmonary Nodules
NCT ID: NCT03181490
Last Updated: 2020-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1490 participants
OBSERVATIONAL
2017-06-08
2019-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Interventions
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Circulating Tumor DNA Methylation Test
Methylation profiling by high-throughput bisulfite DNA sequencing in blood sample to differentiate benign and malignant pulmonary nodules
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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AnchorDx Medical Co., Ltd.
INDUSTRY
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Nanfang Hospital, Southern Medical University
OTHER
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
The First Affiliated Hospital of Guangzhou Medical University
OTHER
Responsible Party
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Jianxing He
Principle Investigator
Principal Investigators
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Jianxing He, MD
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Guangzhou Medical University
Locations
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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, , China
Countries
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Other Identifiers
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CCTC1701
Identifier Type: -
Identifier Source: org_study_id
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