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Multi-omics Detection Techniques for Differentiating Benign and Malignant Pulmonary Nodules

Clinical Application Research on Differentiating Benign and Malignant Pulmonary Nodules Based on Multi-omics Detection Technology

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07047573
Enrollment
150
Registered
2025-07-02
Start date
2025-06-01
Completion date
2026-06-30
Last updated
2025-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer (Diagnosis), Pulmonary Nodule Persistent

Keywords

Cancer immunotherapy, Peripheral Blood, Tumor antigen specific T cells

Brief 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

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

Interventions

BIOLOGICALPBMCS 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

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.

Sponsors

Zhao Jun
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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. * 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

Design outcomes

Primary

MeasureTime frameDescription
Changes in peripheral blood immune indicators, differences in radiomics and clinicopathological characteristicsBefore 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.Before surgery for patients with pulmonary nodulesTumor 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.

Countries

China

Contacts

Primary ContactMi Liu
mi.liu831116@icoud.com86-0512-67972216
Backup ContactJun Zhao
zhaojia0327@126.com86-0512-67972216

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026