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Recruiting NCT07047573

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

Observational Lung Cancer (Diagnosis) Pulmonary Nodule Persistent

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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.
Who it may be relevant to
Registry conditions: Lung Cancer (Diagnosis), Pulmonary Nodule Persistent. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Biological 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
    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

Primary outcome measures

  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

China · 1 center
  • Soochow university — Suzhou

Identifiers

NCT: NCT07047573 · 2024735

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗