Pulmonary Nodule, SolitaryNCT03989219
Methylation of cfDNA in Diagnosing and Monitoring Pulmonary Nodule
An observational study of Pulmonary Nodule, Solitary, run by Jiayuan Sun at 1 site in China.
Trial summary
Patients found pulmonary nodules by CT screening by will be enrolled in this study prospectively. Plasma cfDNA sequencing of these patients will be used to diagnose and monitor benign and malignant pulmonary nodules. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Nodule, Solitary
- What is being tested?
- plasma cfDNA methylation
- Type of treatment
- Surgery or procedure
- How many people
- 401 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2018to 30 Jun 2022
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population of this study are those who meet the inclusion and exclusion criteria.
Who may be able to join
- 1. Inclusion criteria:
- Aged 40-80;
- Lung nodules were detected by CT (≥5mm，≤3cm);
- Patients fully understand the informed consent and can sign the informed consent in person.
Who cannot join
- 2. Exclusion criteria:
- Patients diagnosed with malignant tumors in the past;
- This image suggests pulmonary nodules with hilar or mediastinal lymph node enlargement；
- Pulmonary nodules are suspected of intrapulmonary metastasis of lung cancer or other malignancies；
- Past diseases or conditions that affect plasma cfDNA content, such as rheumatoid immunity and diseases of the blood system.
- The researchers concluded that there were other conditions that made it inappropriate to participate in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Methylation of cfDNA in Diagnosing and Monitoring Benign and Malignant Pulmonary Nodule
Patients found pulmonary nodules by CT screening by will be enrolled in this study prospectively. Plasma cfDNA sequencing of these patients will be used to diagnose and monitor benign and malignant pulmonary nodules.
Read the detailed description
This study prospectively included patients with pulmonary nodules (0.5-3 cm) diagnosed by CT. Methylation of plasma cfDNA in these patients will be performed. Evaluation of benign and malignant diagnostic efficacy of cfDNA methylation in pulmonary nodules with definite pathological findings. Pulmonary nodules that temporarily not require invasive examination will be performed CT follow-up and dynamically monitored methylation changes of cfDNA. And the methylation changes were to establish a model for the diagnosis and monitor of benign and malignant pulmonary nodules.
- Conditions
- Pulmonary Nodule, Solitary
- Being tested
- plasma cfDNA methylation
- Keywords
- cfDNA methylation, CT follow-up, plasma, pulmonary nodule
- 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.
plasma cfDNA methylationProcedure or surgery
plasma cfDNA will be performed in patients with pulmonary nodules (0.5-3 cm) found by CT scanning. Evaluation of benign and malignant diagnostic efficacy of cfDNA methylation in pulmonary nodules with clear pathological findings. Pulmonary nodules that could not or temporarily not require invasive examination will be performed CT follow-up and dynamically monitored methylation changes of cfDNA.
| Study group | Role | What they receive |
|---|---|---|
| lung nodules were found by CT scanning | Plasma cfDNA will be performed in patients with pulmonary nodules (0.5-3 cm) found by CT scanning. Evaluation of benign and malignant diagnostic efficacy of cfDNA methylation in pulmonary nodules with clear pathological findings. Pulmonary nodules that could not or temporarily not require invasive examination will be performed CT follow-up and dynamically monitored methylation changes of cfDNA. Receives: Procedure: plasma cfDNA methylation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of cfDNA methylation in the diagnosis of benign and malignant pulmonary nodules
The sensitivity, specificity, positive predictive value, negative predictive value and accuracy are calculated according to standard definitions to evaluate the efficacy of cfDNA methylation in the diagnosis of benign and malignant pulmonary nodules .
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start15 Aug 2018
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Case only
- Time perspective
- Prospective
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiayuan Sun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiayuan Sun, Shanghai Chest Hospital
- Investigators
- Jiayuan Sun, PhD, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03989219
- Sponsor's protocol ID
- SHCHE201802
- Status last verified
- Aug 2022
- First submitted
- 16 Jun 2019
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li Y, Xie F, Zheng Q, Zhang Y, Li W, Xu M, He Q, Li Y, Sun J. Non-invasive diagnosis of pulmonary nodules by circulating tumor DNA methylation: A prospective multicenter study. Lung Cancer. 2024 Sep;195:107930. doi: 10.1016/j.lungcan.2024.107930. Epub 2024 Aug 11.
PubMed 39146624
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylation of cfDNA in Diagnosing and Monitoring Benign and Malignant Pulmonary Nodule
- ClinicalTrials.gov ID
- NCT03989219
- Acronym / sponsor ID
- SHCHE201802
- Conditions
- Pulmonary Nodule, Solitary
- Keywords
- cfDNA methylation, CT follow-up, plasma, pulmonary nodule
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Jiayuan SunUniversity, hospital or other
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 18 Jun 2019 (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.
Patients found pulmonary nodules by CT screening by will be enrolled in this study prospectively. Plasma cfDNA sequencing of these patients will be used to diagnose and monitor benign and malignant pulmonary nodules.
Detailed description
This study prospectively included patients with pulmonary nodules (0.5-3 cm) diagnosed by CT. Methylation of plasma cfDNA in these patients will be performed. Evaluation of benign and malignant diagnostic efficacy of cfDNA methylation in pulmonary nodules with definite pathological findings. Pulmonary nodules that temporarily not require invasive examination will be performed CT follow-up and dynamically monitored methylation changes of cfDNA. And the methylation changes were to establish a model for the diagnosis and monitor of benign and malignant pulmonary nodules.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lung nodules were found by CT scanning | – | Procedure: plasma cfDNA methylationPlasma cfDNA will be performed in patients with pulmonary nodules (0.5-3 cm) found by CT scanning. Evaluation of benign and malignant diagnostic efficacy of cfDNA methylation in pulmonary nodules with clear pathological findings. Pulmonary nodules that could not or temporarily not require invasive examination will be performed CT follow-up and dynamically monitored methylation changes of cfDNA. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of this study are those who meet the inclusion and exclusion criteria.
Key inclusion criteria (4 listed)
- 1. Inclusion criteria:
Key exclusion criteria (6 listed)
- 2. Exclusion criteria:
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 |
|---|---|---|
| plasma cfDNA methylationplasma cfDNA will be performed in patients with pulmonary nodules (0.5-3 cm) found by CT scanning. Evaluation of benign and malignant diagnostic efficacy of cfDNA methylation in pulmonary nodules with clear pathological findings. Pulmonary nodules that could not or temporarily not require invasive examination will be performed CT follow-up and dynamically monitored methylation changes of cfDNA. | Procedure or surgery | lung nodules were found by CT scanning |
Primary outcome
The efficacy of cfDNA methylation in the diagnosis of benign and malignant pulmonary nodules
Time frame: 12 months
The sensitivity, specificity, positive predictive value, negative predictive value and accuracy are calculated according to standard definitions to evaluate the efficacy of cfDNA methylation in the diagnosis of benign and malignant pulmonary 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 8 Aug 2022.
- Derived from this study: PubMed 39146624Li Y, Xie F, Zheng Q, Zhang Y, Li W, Xu M, He Q, Li Y, Sun J. Non-invasive diagnosis of pulmonary nodules by circulating tumor DNA methylation: A prospective multicenter study. Lung Cancer. 2024 Sep;195:107930. doi: 10.1016/j.lungcan.2024.107930. Epub 2024 Aug 11.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Nodule, Solitary
RecruitingObservational study
Biomarkers for Risk Stratification in Lung Cancer
Nodule Solitary Pulmonary, Non-small Cell Lung Cancer
RecruitingObservational study
European Real-World Registry for Use of the Ion Endoluminal System
Pulmonary Nodule, Lung Cancer
Recruiting
Intraoperative Longitude-Latitude-Depth Localization Versus Preoperative CT-Guided Percutaneous Lung Puncture Localization for 0.8-2 cm Peripheral Pulmonary Nodules
Pulmonary Nodule, Solitary, Peripheral Pulmonary Nodules
Not yet recruitingObservational study
Radiomics for Distinguishing Benign and Malignant Lung Nodules
Solitary Pulmonary Nodule, Lung Neoplasms
Active, not recruiting
Teachable Moment to Opt-out of Tobacco: Interactive Voice Response Quit Line for Veteran Active Smokers With Lung Nodules
Solitary Pulmonary Nodule, Multiple Pulmonary Nodules
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.
Jiayuan Sun, PhD principal investigator
Shanghai Chest Hospital
1 site 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 Jiayuan Sun at 1 site 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 4 inclusion and 6 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 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 efficacy of cfDNA methylation in the diagnosis of benign and malignant pulmonary nodules (time frame: 12 months). 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 NCT03989219, which also lists 1 linked publication.
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 8 Aug 2022.