Diagnostic and Monitoring Significance of ctDNA Methylation Analysis by NGS in Benign and Malignant Pulmonary Nodules

Sponsor

AnchorDx Medical Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03651986

Collaborator

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

10,560

Enrollment

Locations

54.1

Anticipated Duration (Months)

459.1

Patients Per Site

8.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Nodules	Diagnostic Test: ctDNA methylation analysis by NGS

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

10560 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Diagnostic and Monitoring Significance of Circulating Tumor DNA (ctDNA) Methylation Analysis by Next-Generation Sequencing in Benign and Malignant Pulmonary Nodules

Actual Study Start Date :

Nov 26, 2018

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Prospective Cohort This is a prospectively enrolling cohort study and a stratified case-cohort design will be employed to select malignant pulmonary nodules cases and benign pulmonary nodules subjects who will be assayed. All participants will be followed up with chest CT or low-dose computed tomography (LDCT) scans for 2-3 years, and take the diagnostic test, ctDNA methylation analysis by NGS, at each visit.	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)

Arm

Intervention/Treatment

Prospective Cohort

This is a prospectively enrolling cohort study and a stratified case-cohort design will be employed to select malignant pulmonary nodules cases and benign pulmonary nodules subjects who will be assayed. All participants will be followed up with chest CT or low-dose computed tomography (LDCT) scans for 2-3 years, and take the diagnostic test, ctDNA methylation analysis by NGS, at each visit.

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)

Outcome Measures

Primary Outcome Measures

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) [3 Years]
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).

Secondary Outcome Measures

The diagnostic and monitoring significance of routine tests integrating with ctDNA methylation analysis by NGS in differentiating benign and malignant pulmonary nodules [3 Years]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	Country
1	Department of Respiratory and Critical Care Medicine, Beijing Chaoyang Hospital	Beijing	China
2	Xiangya Hospital of Central South University	Changsha	China
3	Department of Respiratory Medicine, West China Hospital of Sichuan University	Chengdu	China
4	Department of Pulmonary Medicine, The First Affiliated Hospital of Sun Yat-Sen University	Guangzhou	China
5	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	China
6	Department of Respiration and Critical Care Medicine, Guizhou Provincial People's Hospital	Guiyang	China
7	Department of Pulmonary and Critical Care Medicine, Inner Mongolia Autonomous Region People's Hospital	Hohhot	China
8	Department of Respiratory, QILU Hospital, Shandong University	Jinan	China
9	Department of Respiratory Medicine, The First People's Hospital of Yunnan Province	Kunming	China
10	Department of Gerontal Respiratory Medicine, The Frist Hospital of Lanzhou University	Lanzhou	China
11	Department of Respiration, The First Affiliated Hospital of Nanchang University	Nanchang	China
12	Department of Pulmonary & Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	China
13	Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiaotong University	Shanghai	China
14	Department of Pulmonary Medicine, Zhongshan Hospital, Fudan University	Shanghai	China
15	Department of Respiratory Medicine, Shanghai Pulmonary Hospital, Tongji University School of Medicine	Shanghai	China
16	Department of Respiratory Medicine, Shantou Central Hospital	Shantou	China
17	Department of Respiratory Medicine, The First Hospital of China Medical University	Shenyang	China
18	Department of Respiratory Medicine, Shenzhen People's Hospital	Shenzhen	China
19	Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	China
20	Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital, Xi'an Jiaotong University	Xi'an	China
21	Department of Pulmonary Medicine, Xijing Hospital, Air Force Medical University of PLA	Xi'an	China
22	Department of Cardiothoracic Surgery, The Second Affiliated Hospital of Xiamen Medical College	Xiamen	China
23	Department of Respiratory Medicine, Henan Provincial People's Hospital	Zhengzhou	China

Sponsors and Collaborators

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

Investigators

Study Chair: Nanshan ZHONG, MD, The First Affiliated Hospital of Guangzhou Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

AnchorDx Medical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT03651986

Other Study ID Numbers:

AnchorDx LC201801

First Posted:

Aug 29, 2018

Last Update Posted:

Mar 24, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by AnchorDx Medical Co., Ltd.

Circulating Tumor DNA (ctDNA)

DNA Methylation Analysis

Next-Generation Sequencing (NGS)

Low-Dose Computed Tomography (LDCT)

Additional relevant MeSH terms:

Multiple Pulmonary Nodules

Study Results

No Results Posted as of Mar 24, 2020