Pulmonary Nodule, SolitaryNCT03181490
Circulating Tumor DNA Methylation Test to Differentiate Benign and Malignant Pulmonary Nodules
An observational study of Pulmonary Nodule, Solitary, run by The First Affiliated Hospital of Guangzhou Medical University at 14 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Nodule, Solitary
- What is being tested?
- Circulating Tumor DNA Methylation Test
- How many people
- 1,490 participants
- Where
- 14 sitesChina
- Study dates
- 8 Jun 2017to 31 May 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Pre-surgery adult patients with single pulmonary nodule found by CT scan.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites
Department of Thoracic Surgery, Beijing Cancer Hospital
Beijing
Department of Thoracic Surgery, Xuanwu Hospital, Capital Medical University
Beijing
Department of Thoracic Surgery, The Second Xiangya Hospital of Central South University
Changsha
Department of Thoracic Surgery, Xiangya Hospital, Central South University
Changsha
Department of Thoracic Surgery, West China Hospital of Sichuan University
Chengdu
Department of Thoracic Surgery, Nanfang Hospital of Southern Medical University
Guangzhou
Department of Thoracic Surgery, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou
Department of Thoracic Surgery, The First Affiliated Hospital of Sun Yat-sen University
Guangzhou
Department of Thoracic Surgery, The Forth Affiliated Hospital of Harbin Medical University
Haerbin
Department of Thoracic Surgery, Anhui Chest Hospital
Hefei
Department of Thoracic Surgery, The Second Hospital，University of South China
Hengyang
Department of Thoracic Surgery, Qilu Hospital of Shandong University
Jinan
Department of Thoracic Surgery, Jiangsu Province Hospital
Nanjing
Department of Thoracic Surgery, Shenzhen People's Hospital
Shenzhen
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Nodule, Solitary
- Being tested
- Circulating Tumor DNA Methylation Test
- Keywords
- Pulmonary Nodule, Solitary
- Medical subject headings
- Solitary Pulmonary Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating Tumor DNA Methylation TestDiagnostic test
Methylation profiling by high-throughput bisulfite DNA sequencing in blood sample to differentiate benign and malignant pulmonary nodules
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, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start8 Jun 2017
- Primary completion28 Feb 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Nodule, SolitaryStudies 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
- Cross-sectional
- Enrolment
- 1,490 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- AnchorDx Medical Co., Ltd., First Affiliated Hospital, Sun Yat-Sen University, Nanfang Hospital, Southern Medical University, Central South University, Xiangya Hospital of Central South University, West China Hospital, Qilu Hospital of Shandong University, The Second Hospital University of South China, Shenzhen People's Hospital, The Fourth Affiliated Hospital of Harbin Medical University, Peking University Cancer Hospital & Institute, Xuanwu Hospital, Beijing, Anhui Chest Hospital, The First Affiliated Hospital with Nanjing Medical University
- Responsible party
- Principal investigator, Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Jianxing He, MD, Principal investigator, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181490
- Sponsor's protocol ID
- CCTC1701
- Status last verified
- Mar 2020
- First submitted
- 7 Jun 2017
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- 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 39341207
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centers Validation of a Circulating Tumor DNA Assay to Differentiate Benign and Malignant Pulmonary Nodules Via Targeted High-throughput DNA Methylation Sequencing
- ClinicalTrials.gov ID
- NCT03181490
- Acronym / sponsor ID
- CCTC1701
- Conditions
- Pulmonary Nodule, Solitary
- Keywords
- Pulmonary Nodule, Solitary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,490 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Collaborators
- AnchorDx Medical Co., Ltd., First Affiliated Hospital, Sun Yat-Sen University, Nanfang Hospital, Southern Medical University, Central South University, Xiangya Hospital of Central South University, West China Hospital, Qilu Hospital of Shandong University, The Second Hospital University of South China, Shenzhen People's Hospital, The Fourth Affiliated Hospital of Harbin Medical University, Peking University Cancer Hospital & Institute, Xuanwu Hospital, Beijing, Anhui Chest Hospital, The First Affiliated Hospital with Nanjing Medical University
- Study start
- 8 Jun 2017 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 8 Jun 2017 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pre-surgery adult patients with single pulmonary nodule found by CT scan.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Circulating Tumor DNA Methylation TestMethylation profiling by high-throughput bisulfite DNA sequencing in blood sample to differentiate benign and malignant pulmonary nodules | Diagnostic test | – |
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: 1 year
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- 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.
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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.
Jianxing He, MD principal investigator
The First Affiliated Hospital of Guangzhou Medical University
14 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 Nodule, Solitary, run by The First Affiliated Hospital of Guangzhou Medical University at 14 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 1 year). 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 NCT03181490, which also lists 2 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 2 Apr 2020; AzTrials last refreshed its copy on 29 Oct 2026.