Pulmonary NodulesNCT03651986
Diagnostic and Monitoring Significance of ctDNA Methylation Analysis by NGS in Benign and Malignant Pulmonary Nodules
An observational study of Pulmonary Nodules, run by AnchorDx Medical Co., Ltd. at 23 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Nodules
- What is being tested?
- ctDNA methylation analysis by NGS
- How many people
- 10,560 participants
- Where
- 23 sitesChina
- Study dates
- 26 Nov 2018to Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with pulmonary nodules diagnosed by chest CT or low-dose computed tomography (LDCT) scans
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
China23 sites
Department of Respiratory and Critical Care Medicine, Beijing Chaoyang Hospital
Beijing
Xiangya Hospital of Central South University
Changsha
Department of Respiratory Medicine, West China Hospital of Sichuan University
Chengdu
Department of Pulmonary Medicine, The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou
Department of Respiration and Critical Care Medicine, Guizhou Provincial People's Hospital
Guiyang
Department of Pulmonary and Critical Care Medicine, Inner Mongolia Autonomous Region People's Hospital
Hohhot
Department of Respiratory, QILU Hospital, Shandong University
Jinan
Department of Respiratory Medicine, The First People's Hospital of Yunnan Province
Kunming
Department of Gerontal Respiratory Medicine, The Frist Hospital of Lanzhou University
Lanzhou
Department of Respiration, The First Affiliated Hospital of Nanchang University
Nanchang
Department of Pulmonary & Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiaotong University
Shanghai
Department of Pulmonary Medicine, Zhongshan Hospital, Fudan University
Shanghai
Department of Respiratory Medicine, Shanghai Pulmonary Hospital, Tongji University School of Medicine
Shanghai
Department of Respiratory Medicine, Shantou Central Hospital
Shantou
Department of Respiratory Medicine, The First Hospital of China Medical University
Shenyang
Department of Respiratory Medicine, Shenzhen People's Hospital
Shenzhen
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital, Xi'an Jiaotong University
Xi'an
Department of Pulmonary Medicine, Xijing Hospital, Air Force Medical University of PLA
Xi'an
Department of Cardiothoracic Surgery, The Second Affiliated Hospital of Xiamen Medical College
Xiamen
Department of Respiratory Medicine, Henan Provincial People's Hospital
Zhengzhou
About this study
Official title: Diagnostic and Monitoring Significance of Circulating Tumor DNA (ctDNA) Methylation Analysis by Next-Generation Sequencing in Benign and Malignant Pulmonary Nodules
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.
Read the 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.
- Conditions
- Pulmonary Nodules
- Being tested
- ctDNA methylation analysis by NGS
- Keywords
- Circulating Tumor DNA (ctDNA), DNA Methylation Analysis, Next-Generation Sequencing (NGS), Low-Dose Computed Tomography (LDCT)
- Medical subject headings
- Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ctDNA methylation analysis by NGSDiagnostic test
A blood-based assay for differentiating benign and malignant pulmonary nodules early using circulating tumor DNA (ctDNA) methylation analysis by next-generation sequencing (NGS)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: ctDNA methylation analysis by NGS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 Years
Secondary outcomes (1)
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).
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start26 Nov 2018
- Primary completionSep 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary NodulesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,560 participants (actual)
Sponsor and investigators
- Lead sponsor
- AnchorDx Medical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Xiangya Hospital of Central South University, West China Hospital, Shanghai Zhongshan Hospital, Shanghai Pulmonary Hospital, Shanghai, China, 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, Tongji Hospital, The First Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Air Force Medical University, Shenzhen People's Hospital, Henan Provincial People's Hospital, Beijing Chao Yang Hospital, Xiamen Second Hospital, The First Affiliated Hospital of Nanchang University
- Responsible party
- Sponsor
- Investigators
- Nanshan ZHONG, MD, Study chair, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651986
- Sponsor's protocol ID
- AnchorDx LC201801
- Status last verified
- May 2023
- First submitted
- 27 Aug 2018
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zeng F, Wang B, Peng M, Tao J, Tu X, Lu H, Qiu X, Yang Y, Wang W, Zeng M, Fan JB, Zeng Q, Liu Q. Comparison of clinical-radiological and radiomics features for predicting pulmonary nodule malignancy in a multicenter study of mixed clinical and surveillance populations. Eur Radiol. 2026 Jul;36(7):6179-6192. doi: 10.1007/s00330-026-12437-3. Epub 2026 Mar 14.
PubMed 41831027Liang W, Tao J, Cheng C, Sun H, Ye Z, Wu S, Guo Y, Zhang J, Chen Q, Liu D, Liu L, Tian H, Teng L, Zhong N, Fan JB, He J. A clinically effective model based on cell-free DNA methylation and low-dose CT for risk stratification of pulmonary nodules. Cell Rep Med. 2024 Oct 15;5(10):101750. doi: 10.1016/j.xcrm.2024.101750. Epub 2024 Sep 27.
PubMed 39341207Liang W, Liu D, Li M, Wang W, Qin Z, Zhang J, Zhang Y, Hu Y, Bao H, Xiang Y, Wang B, Wu J, Sun J, Hu C, Ye X, Zhang X, Xiao W, Yun C, Sun D, Wang W, Chang N, Zhang Y, Zhao J, Zhang X, Xu J, Wu D, Liu X, Guo Y, Zhang Q, Zhang W, Yang L, Li Z, Zhang X, Han B, Tong Z, He J, Qu J, Fan JB, Zhong N. Evaluating the diagnostic accuracy of a ctDNA methylation classifier for incidental lung nodules: protocol for a prospective, observational, and multicenter clinical trial of 10,560 cases. Transl Lung Cancer Res. 2020 Oct;9(5):2016-2026. doi: 10.21037/tlcr-20-701.
PubMed 33209621
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Monitoring Significance of Circulating Tumor DNA (ctDNA) Methylation Analysis by Next-Generation Sequencing in Benign and Malignant Pulmonary Nodules
- ClinicalTrials.gov ID
- NCT03651986
- Acronym / sponsor ID
- AnchorDx LC201801
- Conditions
- Pulmonary Nodules
- Keywords
- Circulating Tumor DNA (ctDNA), DNA Methylation Analysis, Next-Generation Sequencing (NGS), Low-Dose Computed Tomography (LDCT)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,560 participants (actual)
- Lead sponsor
- AnchorDx Medical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Xiangya Hospital of Central South University, West China Hospital, Shanghai Zhongshan Hospital, Shanghai Pulmonary Hospital, Shanghai, China, 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, Tongji Hospital, The First Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Air Force Medical University, Shenzhen People's Hospital, Henan Provincial People's Hospital, Beijing Chao Yang Hospital, Xiamen Second Hospital, The First Affiliated Hospital of Nanchang University
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 29 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective Cohort | – | Diagnostic Test: ctDNA methylation analysis by NGSThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with pulmonary nodules diagnosed by chest CT or low-dose computed tomography (LDCT) scans
Key inclusion criteria (8 listed)
- 18 Years and older
- pulmonary nodules diagnosed by chest CT or low-dose computed tomography (LDCT) scans
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ctDNA methylation analysis by NGSA blood-based assay for differentiating benign and malignant pulmonary nodules early using circulating tumor DNA (ctDNA) methylation analysis by next-generation sequencing (NGS) | Diagnostic test | Prospective Cohort |
Primary outcome
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: 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).
1 secondary outcome
The diagnostic and monitoring significance of routine tests integrating with ctDNA methylation analysis by NGS in differentiating benign and malignant pulmonary nodules
Time frame: 3 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Derived from this study: PubMed 41831027Zeng F, Wang B, Peng M, Tao J, Tu X, Lu H, Qiu X, Yang Y, Wang W, Zeng M, Fan JB, Zeng Q, Liu Q. Comparison of clinical-radiological and radiomics features for predicting pulmonary nodule malignancy in a multicenter study of mixed clinical and surveillance populations. Eur Radiol. 2026 Jul;36(7):6179-6192. doi: 10.1007/s00330-026-12437-3. Epub 2026 Mar 14.
- Derived from this study: PubMed 39341207Liang W, Tao J, Cheng C, Sun H, Ye Z, Wu S, Guo Y, Zhang J, Chen Q, Liu D, Liu L, Tian H, Teng L, Zhong N, Fan JB, He J. A clinically effective model based on cell-free DNA methylation and low-dose CT for risk stratification of pulmonary nodules. Cell Rep Med. 2024 Oct 15;5(10):101750. doi: 10.1016/j.xcrm.2024.101750. Epub 2024 Sep 27.
- Derived from this study: PubMed 33209621Liang W, Liu D, Li M, Wang W, Qin Z, Zhang J, Zhang Y, Hu Y, Bao H, Xiang Y, Wang B, Wu J, Sun J, Hu C, Ye X, Zhang X, Xiao W, Yun C, Sun D, Wang W, Chang N, Zhang Y, Zhao J, Zhang X, Xu J, Wu D, Liu X, Guo Y, Zhang Q, Zhang W, Yang L, Li Z, Zhang X, Han B, Tong Z, He J, Qu J, Fan JB, Zhong N. Evaluating the diagnostic accuracy of a ctDNA methylation classifier for incidental lung nodules: protocol for a prospective, observational, and multicenter clinical trial of 10,560 cases. Transl Lung Cancer Res. 2020 Oct;9(5):2016-2026. doi: 10.21037/tlcr-20-701.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nanshan ZHONG, MD study chair
The First Affiliated Hospital of Guangzhou Medical University
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Nodules, run by AnchorDx Medical Co., Ltd. at 23 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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: 3 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03651986, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.