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

NCT07047573 | Recruiting

• 1 other identifier: 2024735
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Lung Cancer (Diagnosis); Pulmonary Nodule Persistent

Keywords

Cancer immunotherapy; Peripheral Blood; Tumor antigen specific T cells

Outcome Measures

Primary Outcomes (2)

• Changes in peripheral blood immune indicators, differences in radiomics and clinicopathological characteristics

  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.

  Before surgery for patients with pulmonary nodules

Interventions

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 BIOLOGICAL

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhao Jun: lead

Study Sites (1)

Soochow university

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Disease

Interventions

Antigens, Neoplasm

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antigens; Biological Factors

Central Study Contacts

Mi Liu

CONTACT

86-0512-67972216; mi.liu831116@icoud.com

Jun Zhao

CONTACT

86-0512-67972216; zhaojia0327@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Thoracic Surgery

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 2, 2025

Record last verified: 2025-06

Locations

CN (1)