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临床试验/NCT07047573
NCT07047573招募中不适用

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

Zhao Jun1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年6月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
Changes in peripheral blood immune indicators, differences in radiomics and clinicopathological characteristics

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

结局指标

主要结局

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

时间窗: 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.

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Zhao Jun
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zhao Jun

Thoracic Surgery

The First Affiliated Hospital of Soochow University

研究点 (1)

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