- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03181490
Circulating Tumor DNA Methylation Test to Differentiate Benign and Malignant Pulmonary Nodules
Multi-centers Validation of a Circulating Tumor DNA Assay to Differentiate Benign and Malignant Pulmonary Nodules Via Targeted High-throughput DNA Methylation Sequencing
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Beijing, China
- Department of Thoracic Surgery, Beijing Cancer Hospital
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Beijing, China
- Department of Thoracic Surgery, Xuanwu Hospital, Capital Medical University
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Changsha, China
- Department of Thoracic Surgery, The Second Xiangya Hospital of Central South University
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Changsha, China
- Department of Thoracic Surgery, Xiangya Hospital, Central South University
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Chengdu, China
- Department of Thoracic Surgery, West China Hospital of Sichuan University
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Guangzhou, China
- Department of Thoracic Surgery, Nanfang Hospital of Southern Medical University
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Guangzhou, China
- Department of Thoracic Surgery, The First Affiliated Hospital of Guangzhou Medical University
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Guangzhou, China
- Department of Thoracic Surgery, The First Affiliated Hospital of Sun Yat-sen University
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Haerbin, China
- Department of Thoracic Surgery, The Forth Affiliated Hospital of Harbin Medical University
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Hefei, China
- Department of Thoracic Surgery, Anhui Chest Hospital
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Hengyang, China
- Department of Thoracic Surgery, The Second Hospital,University of South China
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Jinan, China
- Department of Thoracic Surgery, Qilu Hospital of Shandong University
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Nanjing, China
- Department of Thoracic Surgery, Jiangsu Province Hospital
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Shenzhen, China
- Department of Thoracic Surgery, Shenzhen People's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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)
Time Frame: 1 year
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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
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCTC1701
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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