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
1 other identifier
observational
1,490
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2017
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2017
CompletedFirst Posted
Study publicly available on registry
June 8, 2017
CompletedStudy Start
First participant enrolled
June 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2019
CompletedApril 2, 2020
March 1, 2020
1.7 years
June 7, 2017
March 31, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Interventions
Methylation profiling by high-throughput bisulfite DNA sequencing in blood sample to differentiate benign and malignant pulmonary nodules
Eligibility Criteria
Pre-surgery adult patients with single pulmonary nodule found by CT scan.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The First Affiliated Hospital of Guangzhou Medical Universitylead
- AnchorDx Medical Co., Ltd.collaborator
- First Affiliated Hospital, Sun Yat-Sen Universitycollaborator
- Nanfang Hospital, Southern Medical Universitycollaborator
- Central South Universitycollaborator
- Xiangya Hospital of Central South Universitycollaborator
- West China Hospitalcollaborator
- Qilu Hospital of Shandong Universitycollaborator
- The Second Hospital University of South Chinacollaborator
- Shenzhen People's Hospitalcollaborator
- The Fourth Affiliated Hospital of Harbin Medical Universitycollaborator
- Peking University Cancer Hospital & Institutecollaborator
- Xuanwu Hospital, Beijingcollaborator
- Anhui Chest Hospitalcollaborator
- The First Affiliated Hospital with Nanjing Medical Universitycollaborator
Study Sites (14)
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
Biospecimen
whole blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianxing He, MD
The First Affiliated Hospital of Guangzhou Medical University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
June 7, 2017
First Posted
June 8, 2017
Study Start
June 8, 2017
Primary Completion
February 28, 2019
Study Completion
May 31, 2019
Last Updated
April 2, 2020
Record last verified: 2020-03