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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03651986
Other study ID # AnchorDx LC201801
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 26, 2018
Est. completion date June 2025

Study information

Verified date May 2023
Source AnchorDx Medical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

AnchorDx is using circulating tumor DNA (ctDNA) methylation analysis by next-generation sequencing (NGS) to develop a blood-based assay for differentiating benign and malignant pulmonary nodules early. The purpose of this study is to evaluate the diagnostic performance of this assay in patients with pulmonary nodules.


Description:

This is a prospective, multi-center, observational cohort study and seeks to enroll 10,560 participants with pulmonary nodules smaller than 3 cm in diameter from 21 hospitals in China. All participants will be followed up with chest CT or low-dose computed tomography (LDCT) scans for 2-3 years ( baseline, 3 months, 6 months, 12 months, 24 months and 36 months). Their blood samples, CT or LDCT scans data, and clinical data will be collected at each visit and Formalin-fixed paraffin-embedded (FFPE) tissues will be collected when participants who receive pneumonectomy or percutaneous lung biopsy.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 10560
Est. completion date June 2025
Est. primary completion date September 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 Years and older - pulmonary nodules diagnosed by chest CT or low-dose computed tomography (LDCT) scans - non-calcified pulmonary nodules with the diameter between 5mm to 30mm - including solid nodules, mixed ground-glass opacity nodules and pure ground-glass opacity lung modules - new cases of pulmonary nodules or diagnosed within 60 days prior to enrollment - agree to finish the Patient Pulmonary History Questionnaire - agree to be followed up for 2-3 years - agree to provide a written informed consent Exclusion Criteria: - pregnant or lactating women - received any pneumonectomy or percutaneous lung biopsy before enrollment - recipients of blood transfusions within 30 days prior to enrollment - patients with tumors identified within 2 years prior to enrollment except non-melanoma skin cancer - fail to understand or provide a written informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
ctDNA methylation analysis by NGS
A blood-based assay for differentiating benign and malignant pulmonary nodules early using circulating tumor DNA (ctDNA) methylation analysis by next-generation sequencing (NGS)

Locations

Country Name City State
China Department of Respiratory and Critical Care Medicine, Beijing Chaoyang Hospital Beijing
China Xiangya Hospital of Central South University Changsha
China Department of Respiratory Medicine, West China Hospital of Sichuan University Chengdu
China Department of Pulmonary Medicine, The First Affiliated Hospital of Sun Yat-Sen University Guangzhou
China The First Affiliated Hospital of Guangzhou Medical University Guangzhou
China Department of Respiration and Critical Care Medicine, Guizhou Provincial People's Hospital Guiyang
China Department of Pulmonary and Critical Care Medicine, Inner Mongolia Autonomous Region People's Hospital Hohhot
China Department of Respiratory, QILU Hospital, Shandong University Jinan
China Department of Respiratory Medicine, The First People's Hospital of Yunnan Province Kunming
China Department of Gerontal Respiratory Medicine, The Frist Hospital of Lanzhou University Lanzhou
China Department of Respiration, The First Affiliated Hospital of Nanchang University Nanchang
China Department of Pulmonary & Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai
China Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiaotong University Shanghai
China Department of Pulmonary Medicine, Zhongshan Hospital, Fudan University Shanghai
China Department of Respiratory Medicine, Shanghai Pulmonary Hospital, Tongji University School of Medicine Shanghai
China Department of Respiratory Medicine, Shantou Central Hospital Shantou
China Department of Respiratory Medicine, The First Hospital of China Medical University Shenyang
China Department of Respiratory Medicine, Shenzhen People's Hospital Shenzhen
China Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology Wuhan
China Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital, Xi'an Jiaotong University Xi'an
China Department of Pulmonary Medicine, Xijing Hospital, Air Force Medical University of PLA Xi'an
China Department of Cardiothoracic Surgery, The Second Affiliated Hospital of Xiamen Medical College Xiamen
China Department of Respiratory Medicine, Henan Provincial People's Hospital Zhengzhou

Sponsors (28)

Lead Sponsor Collaborator
AnchorDx Medical Co., Ltd. Beijing Chao Yang Hospital, First Affiliated Hospital Xi'an Jiaotong University, First Affiliated Hospital, Sun Yat-Sen University, First Hospital of China Medical University, Guizhou Provincial People's Hospital, Henan Provincial People's Hospital, Inner Mongolia People's Hospital, LanZhou University, Peking University Third Hospital, Qilu Hospital of Shandong University, Ruijin Hospital, The Shanghai Jiao Tong University Medical School, Second Hospital of Jilin University, Shanghai Chest Hospital, Shanghai Pulmonary Hospital affiliated to Tongji University, Shanghai Zhongshan Hospital, Shantou Affiliated Hospital of Sun Yat-Sen University, Shenzhen People's Hospital, The First Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Nanchang University, The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital with Nanjing Medical University, The First People's Hospital of Yunnan, Tongji Hospital, West China Hospital, Xiamen Second Hospital, Xiangya Hospital of Central South University, Xijing Hospital, Air Force Medical University of PLA

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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, and CT/LDCT diagnosis, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV). 3 Years
Secondary The diagnostic and monitoring significance of routine tests integrating with ctDNA methylation analysis by NGS in differentiating benign and malignant pulmonary nodules The diagnostic performance of the combination of routine tests and ctDNA methylation analysis by NGS in differentiating benign and malignant pulmonary nodules, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV). 3 Years
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