Pulmonary Nodule, SolitaryNCT05415670
Benign/Malignant Pulmonary Nodule Classification Based on High-throughput Whole-genome Methylation Sequencing(GM-seq)
An observational study of Pulmonary Nodule, Solitary and Whole-genome Methylation Sequencing, run by Geneplus-Beijing Co. Ltd. at 2 sites in China.
Trial summary
Lung cancer is the first cancer in China in terms of morbidity and mortality. The problem of early diagnosis/treatment has always been concerned. The popularization of chest CT (electronic computed tomography) screening makes it possible to detect lung cancer early. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Nodule, Solitary, Whole-genome Methylation Sequencing
- What is being tested?
- Whole-genome Methylation Sequencing(GM-seq)
- How many people
- 158 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jul 2023to 1 Aug 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with pulmonary nodules suspected of early lung cancer
Who may be able to join
- Male or female, 20-75 year-old with pulmonary nodules 1-3cm in diameter confirmed by chest CT;
- The nodules are single or multiple, suspected to be malignant, and have the indication of surgical resection;
- Patient accept imaging evaluation without advanced lung tumors and metastases;
- The location of the nodule in the lung is within the reach of lung biopsy under bronchoscope;
- provide the collected clinical data needed by the research;
- Patients have the ability to follow the planned schedule and actively cooperate to return to the hospital for regular clinical visits.
Who cannot join
- Unwilling to accept the invasive examination and treatment of this study;
- Contraindication of tracheoscopy;
- Consider that the pulmonary nodules are metastatic tumors or unresectable advanced lung cancer;
- Those who cannot tolerate resection of pulmonary nodules;
- Accompanied by other malignant tumors;
- In the judgment of the researcher, the patient also suffers from other serious diseases that may affect the accuracy of the test;
- Those who cannot accept the use of contrast-enhanced magnetic resonance imaging (MRI) or contrast-enhanced computed tomography (CT);
- Any other illness, social / psychological problems, etc. are judged by the researcher to be unsuitable for participating in this study.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Emergency general hospital
Beijing, Beijing Municipality, 100028
Beijing hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Development a Pulmonary Nodules Diagnosis Classification Model for Benign/Malignant of Bronchoscopic Biopsy Specimens Based on High-throughput Whole-genome Methylation Sequencing(GM-seq)
Lung cancer is the first cancer in China in terms of morbidity and mortality. The problem of early diagnosis/treatment has always been concerned. The popularization of chest CT (electronic computed tomography) screening makes it possible to detect lung cancer early. However, the diagnosis still needs pathological evidence. It is an ideal choice to obtain pathological evidence through bronchoscope and other minimally invasive means before surgical resection. However, the positive rate of tracheoscopy is still unsatisfactory, which is related to the difficulty of traditional pathological detection in detecting small specimens obtained by tracheoscopy. Liquid biopsy technology based on methylation detection has been used in early cancer screening, but its advantages have not been fully exploited due to the low content of ctDNA (circulating tumor DNA) in the current detection samples. Therefore, through prospective clinical research, the investigators plan to combine the methylation detection technology based on "Whole genome methylation sequencing(GM-seq)" with tracheoscopy, compare the traditional pathological methods with methylation detection on the bronchoscopic samples of lung nodule subjects suspected of early lung cancer, and take the postoperative pathology as the gold standard for judging benign and malignant, to confirm the feasibility and advantages of the new technology.
- Being tested
- Whole-genome Methylation Sequencing(GM-seq)
- Keywords
- ctDNA, Pulmonary Nodule, Solitary, Whole-genome Methylation Sequencing(GM-seq), Machine learning
- 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.
Whole-genome Methylation Sequencing(GM-seq)Diagnostic test
A Whole-genome Methylation detection method, which can analyze the genome-wide, single base resolution methylation of tissue / blood samples, and is used to develop a benign and malignant classification model for Pulmonary Nodule.
| Study group | Role | What they receive |
|---|---|---|
| [Training set, N=80] Benign/Malignant Pulmonary Nodule | This is a prospective training-set cohort study. A stratified case-cohort design will be used to select patients with malignant pulmonary nodules and patients with benign pulmonary nodules for analysis. All participants will receive chest CT or low-dose computed tomography (LD-CT) scanning and detection of serum tumor markers, and receive Whole-genome methylation sequencing at baseline. GM-seq will perform methylation analysis to build a prediction model for benign and malignant classification. Receives: Diagnostic Test: Whole-genome Methylation Sequencing(GM-seq) | |
| [Verification set, N=40] Benign/Malignant Pulmonary Nodule | This is a prospective validation-set cohort study. A stratified case-cohort design was used to select patients with malignant pulmonary nodules and patients with benign pulmonary nodules for analysis. All participants will verify the benign and malignant differentiation model based on GM-seq methylation analysis, and compare the results with histopathological benign and malignant results, so as to develop a clinical benign and malignant differentiation model. Receives: Diagnostic Test: Whole-genome Methylation Sequencing(GM-seq) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the receiver operating characteristic curve (ROC)
Area under curve (AUC) of GM-seq data in discriminating malignant nodules from benign nodules.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start1 Jul 2023
- Primary completion1 Jun 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geneplus-Beijing Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Hospital, Emergency General Hospital
- Responsible party
- Sponsor
- Investigators
- Wei Zhou, Doctor, Study chair, Beijing HospitalYunzhi Zhou, Doctor, Study director, Emergency General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415670
- Sponsor's protocol ID
- GM-Lung diagnosis
- Status last verified
- Aug 2025
- First submitted
- 8 Jun 2022
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development a Pulmonary Nodules Diagnosis Classification Model for Benign/Malignant of Bronchoscopic Biopsy Specimens Based on High-throughput Whole-genome Methylation Sequencing(GM-seq)
- ClinicalTrials.gov ID
- NCT05415670
- Acronym / sponsor ID
- GM-Lung diagnosis
- Keywords
- ctDNA, Pulmonary Nodule, Solitary, Whole-genome Methylation Sequencing(GM-seq), Machine learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Geneplus-Beijing Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Beijing Hospital, Emergency General Hospital
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 13 Jun 2022 (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.
Lung cancer is the first cancer in China in terms of morbidity and mortality. The problem of early diagnosis/treatment has always been concerned. The popularization of chest CT (electronic computed tomography) screening makes it possible to detect lung cancer early. However, the diagnosis still needs pathological evidence. It is an ideal choice to obtain pathological evidence through bronchoscope and other minimally invasive means before surgical resection. However, the positive rate of tracheoscopy is still unsatisfactory, which is related to the difficulty of traditional pathological detection in detecting small specimens obtained by tracheoscopy. Liquid biopsy technology based on methylation detection has been used in early cancer screening, but its advantages have not been fully exploited due to the low content of ctDNA (circulating tumor DNA) in the current detection samples. Therefore, through prospective clinical research, the investigators plan to combine the methylation detection technology based on "Whole genome methylation sequencing(GM-seq)" with tracheoscopy, compare the traditional pathological methods with methylation detection on the bronchoscopic samples of lung nodule subjects suspected of early lung cancer, and take the postoperative pathology as the gold standard for judging benign and malignant, to confirm the feasibility and advantages of the new technology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| [Training set, N=80] Benign/Malignant Pulmonary Nodule | – | Diagnostic Test: Whole-genome Methylation Sequencing(GM-seq)This is a prospective training-set cohort study. A stratified case-cohort design will be used to select patients with malignant pulmonary nodules and patients with benign pulmonary nodules for analysis. All participants will receive chest CT or low-dose computed tomography (LD-CT) scanning and detection of serum tumor markers, and receive Whole-genome methylation sequencing at baseline. GM-seq will perform methylation analysis to build a prediction model for benign and malignant classification. |
| [Verification set, N=40] Benign/Malignant Pulmonary Nodule | – | Diagnostic Test: Whole-genome Methylation Sequencing(GM-seq)This is a prospective validation-set cohort study. A stratified case-cohort design was used to select patients with malignant pulmonary nodules and patients with benign pulmonary nodules for analysis. All participants will verify the benign and malignant differentiation model based on GM-seq methylation analysis, and compare the results with histopathological benign and malignant results, so as to develop a clinical benign and malignant differentiation model. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with pulmonary nodules suspected of early lung cancer
Key inclusion criteria (6 listed)
- Male or female, 20-75 year-old with pulmonary nodules 1-3cm in diameter confirmed by chest CT;
- The nodules are single or multiple, suspected to be malignant, and have the indication of surgical resection;
- Patient accept imaging evaluation without advanced lung tumors and metastases;
- The location of the nodule in the lung is within the reach of lung biopsy under bronchoscope;
- provide the collected clinical data needed by the research;
Key exclusion criteria (8 listed)
- Unwilling to accept the invasive examination and treatment of this study;
- Contraindication of tracheoscopy;
- Consider that the pulmonary nodules are metastatic tumors or unresectable advanced lung cancer;
- Those who cannot tolerate resection of pulmonary nodules;
- Accompanied by other malignant tumors;
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 |
|---|---|---|
| Whole-genome Methylation Sequencing(GM-seq)A Whole-genome Methylation detection method, which can analyze the genome-wide, single base resolution methylation of tissue / blood samples, and is used to develop a benign and malignant classification model for Pulmonary Nodule. | Diagnostic test | [Training set, N=80] Benign/Malignant Pulmonary Nodule, [Verification set, N=40] Benign/Malignant Pulmonary Nodule |
Primary outcome
Area under the receiver operating characteristic curve (ROC)
Time frame: 2 years
Area under curve (AUC) of GM-seq data in discriminating malignant nodules from benign nodules.
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 4 Sep 2025.
- 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.
Wei Zhou, Doctor study chair
Beijing Hospital
Yunzhi Zhou, Doctor study director
Emergency General Hospital
2 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 and Whole-genome Methylation Sequencing, run by Geneplus-Beijing Co. Ltd. at 2 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 8 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 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Area under the receiver operating characteristic curve (ROC) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2025.