Lung Cancer (Diagnosis)NCT07047573
Multi-omics Detection Techniques for Differentiating Benign and Malignant Pulmonary Nodules
An observational study of Lung Cancer (Diagnosis) and Pulmonary Nodule Persistent, run by Zhao Jun at 1 site in China.
Trial summary
Research objective: To explore the clinical application effect of multi-omics detection based on flow cytometry analysis, single-cell data and images combined with clinical features in differentiating the benign and malignant nature of pulmonary nodules and the early diagnosis of lung cancer Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer (Diagnosis), Pulmonary Nodule Persistent
- What is being tested?
- PBMCS were isolated from the peripheral blood of hospitalized patients with pulmonary nodules and incubated with nanoparticles loaded with tumor antigens for a specific period of time to detect cancer
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to Jun 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The patient must be an inpatient of our hospital, have undergone ct examination and been confirmed as having pulmonary nodules, and have received surgical treatment with a clear pathological diagnosis. The medical records are complete and available for follow-up visits.
Who may be able to join
- Patient underwent a ct examination
- Patient was confirmed to have pulmonary nodules
- Patient has been determined to undergo surgical treatment
- There are clear pathological results
- The clinicopathological data are complete
Who cannot join
- Patient has no ct examination results
- Refuse surgical treatment
- Patient has no clear pathological diagnosis
- Patients with hematogenic infectious diseases, such as HIV, hepatitis B or hepatitis C.
- Patients with tumor emergencies that require immediate treatment.
- Poor vascular conditions.
Show all 10Show fewer
- Abnormal coagulation function or receiving anticoagulant or thrombolytic therapy.
- Patients with hematogenic infectious diseases, such as HBV.
- Patients with psychiatric disorders or severe mental illnesses.
- Patients who have difficulty communicating or are unable to be followed up for a long time
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Soochow university
Suzhou, Jiangsu, 215000
Kang Hu, 86+15103662891, wfhk04@126.com
About this study
Official title: Clinical Application Research on Differentiating Benign and Malignant Pulmonary Nodules Based on Multi-omics Detection Technology
Research objective: To explore the clinical application effect of multi-omics detection based on flow cytometry analysis, single-cell data and images combined with clinical features in differentiating the benign and malignant nature of pulmonary nodules and the early diagnosis of lung cancer
Read the detailed description
Research design: It is planned to collect pulmonary nodules confirmed by preoperative CT during the period from January 2021 to June 2020 The peripheral blood and clinical information of 100 patients who underwent surgical operations were classified according to the pathological diagnosis of the patients It is the malignant pulmonary nodule group and the benign pulmonary nodule group. Through single-cell sequencing, flow cytometry analysis and radiomics The purpose of identifying the benign and malignant nature of pulmonary nodules is: ① To predict the benign and malignant nature of pulmonary nodules before surgery; ② Explore evil the differences in the immune microenvironment between patients with sexual and benign pulmonary nodules, and the search for specific markers with clinical value Object ③ Compare the diagnostic sensitivity of the new prediction method with that of traditional tumor markers and explore its role as a predictor The potential for measuring the benign and malignant nature of pulmonary nodules
- Being tested
- PBMCS were isolated from the peripheral blood of hospitalized patients with pulmonary nodules and incubated with nanoparticles loaded with tumor antigens for a specific period of time to detect cancer
- Keywords
- Cancer immunotherapy, Peripheral Blood, Tumor antigen specific T cells
- Medical subject headings
- Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBMCS were isolated from the peripheral blood of hospitalized patients with pulmonary nodules and incubated with nanoparticles loaded with tumor antigens for a specific period of time to detect cancerBiological
Research on the in vitro Stimulation of Pbmc by Tumor Antigen Nanoparticles PBMCS were isolated from the peripheral blood of hospitalized patients with pulmonary nodules and incubated with nanoparticles loaded with tumor antigens for a specific period of time to detect cancer-related T cells or cytokines in vitro. The content of this type of T cells or cytokines is positively correlated with tumors. On the contrary, the content of T cells or cytokines in patients with benign pulmonary nodules is negatively correlated with the tumor. Furthermore, the benign and malignant nature of pulmonary nodules in patients is determined through the combination of patient imaging data and clinicopathological data.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in peripheral blood immune indicators, differences in radiomics and clinicopathological characteristics
Measured: Before surgery for patients with pulmonary nodules
Tumor antigen-specific T cells were detected by flow cytometry or single-cell sequencing to determine the differences in the immune microenvironment between patients with benign pulmonary nodules and those with malignant pulmonary nodules.
Tumor antigen-specific T cells were detected by flow cytometry or single-cell sequencing to determine the differences in the immune microenvironment between patients with benign pulmonary nodules and those with malignant pulmonary nodules. The flow cytometry antibodies used to label activated T cells in this study include CD19, CD3, CD4, CD8.
CD25, CD39, CD137,Foxp3, IFN γ, etc.
Measured: Before surgery for patients with pulmonary nodules
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start1 Jun 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Diagnosis)Studies 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-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Zhao Jun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhao Jun, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047573
- Sponsor's protocol ID
- 2024735
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application Research on Differentiating Benign and Malignant Pulmonary Nodules Based on Multi-omics Detection Technology
- ClinicalTrials.gov ID
- NCT07047573
- Acronym / sponsor ID
- 2024735
- Keywords
- Cancer immunotherapy, Peripheral Blood, Tumor antigen specific T cells
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Zhao JunUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 2 Jul 2025 (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.
Research objective: To explore the clinical application effect of multi-omics detection based on flow cytometry analysis, single-cell data and images combined with clinical features in differentiating the benign and malignant nature of pulmonary nodules and the early diagnosis of lung cancer
Detailed description
Research design: It is planned to collect pulmonary nodules confirmed by preoperative CT during the period from January 2021 to June 2020 The peripheral blood and clinical information of 100 patients who underwent surgical operations were classified according to the pathological diagnosis of the patients It is the malignant pulmonary nodule group and the benign pulmonary nodule group. Through single-cell sequencing, flow cytometry analysis and radiomics The purpose of identifying the benign and malignant nature of pulmonary nodules is: ① To predict the benign and malignant nature of pulmonary nodules before surgery; ② Explore evil the differences in the immune microenvironment between patients with sexual and benign pulmonary nodules, and the search for specific markers with clinical value Object ③ Compare the diagnostic sensitivity of the new prediction method with that of traditional tumor markers and explore its role as a predictor The potential for measuring the benign and malignant nature of pulmonary nodules
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patient must be an inpatient of our hospital, have undergone ct examination and been confirmed as having pulmonary nodules, and have received surgical treatment with a clear pathological diagnosis. The medical records are complete and available for follow-up visits.
Key inclusion criteria (5 listed)
- Patient underwent a ct examination
- Patient was confirmed to have pulmonary nodules
- Patient has been determined to undergo surgical treatment
- There are clear pathological results
- The clinicopathological data are complete
Key exclusion criteria (10 listed)
- Patient has no ct examination results
- Refuse surgical treatment
- Patient has no clear pathological diagnosis
- Patients with hematogenic infectious diseases, such as HIV, hepatitis B or hepatitis C.
- Patients with tumor emergencies that require immediate treatment.
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 |
|---|---|---|
| PBMCS were isolated from the peripheral blood of hospitalized patients with pulmonary nodules and incubated with nanoparticles loaded with tumor antigens for a specific period of time to detect cancerResearch on the in vitro Stimulation of Pbmc by Tumor Antigen Nanoparticles PBMCS were isolated from the peripheral blood of hospitalized patients with pulmonary nodules and incubated with nanoparticles loaded with tumor antigens for a specific period of time to detect cancer-related T cells or cytokines in vitro. The content of this type of T cells or cytokines is positively correlated with tumors. On the contrary, the content of T cells or cytokines in patients with benign pulmonary nodules is negatively correlated with the tumor. Furthermore, the benign and malignant nature of pulmonary nodules in patients is determined through the combination of patient imaging data and clinicopathological data. | Biological | – |
Primary outcome
Changes in peripheral blood immune indicators, differences in radiomics and clinicopathological characteristics
Time frame: Before surgery for patients with pulmonary nodules
Tumor antigen-specific T cells were detected by flow cytometry or single-cell sequencing to determine the differences in the immune microenvironment between patients with benign pulmonary nodules and those with malignant pulmonary nodules.
Time frame: Before surgery for patients with pulmonary nodules
Tumor antigen-specific T cells were detected by flow cytometry or single-cell sequencing to determine the differences in the immune microenvironment between patients with benign pulmonary nodules and those with malignant pulmonary nodules. The flow cytometry antibodies used to label activated T cells in this study include CD19, CD3, CD4, CD8. CD25, CD39, CD137,Foxp3, IFN γ, etc.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Lung Cancer (Diagnosis)
Recruiting
MRD-Guided Postoperative Surveillance and Adaptive Treatment for Resectable Lung Cancer
Lung Neoplasms, Neoadjuvant Therapy
Active, not recruitingPhase 3
A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer
Non-small Cell Lung Cancer Stage IV
RecruitingObservational study
Label-free Femtosecond Laser Imaging Combined With the Fast Lung Artificial Intelligence Model for Rapid Intraoperative Diagnosis of Lung Surgical Specimens: A Multicentre, Prospective, Parallel-workflow, Non-inferiority Study.
Lung Cancer
RecruitingPhase 3
A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
Non-small Cell Lung Cancer
RecruitingPhase 1/2
Efficacy and Safety of Ivonescimab Plus Pemetrexed and Platinum-Based Chemotherapy in Advanced Malignant Pleural Mesothelioma
Malignant Pleural Mesothelioma, Advanced
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.
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 Lung Cancer (Diagnosis) and Pulmonary Nodule Persistent, run by Zhao Jun 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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 2 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mi Liu (86-0512-67972216, mi.liu831116@icoud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in peripheral blood immune indicators, differences in radiomics and clinicopathological characteristics (time frame: Before surgery for patients with pulmonary nodules). The study lists 2 primary outcomes in all. 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 2 Jul 2025.