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临床试验/NCT05742204
NCT05742204进行中(未招募)不适用

Identification and Functional Verification Study in Plasma Proteomic Biomarkers for Early Diagnosis of Lung Cancer

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 3,700 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
3,700
试验地点
1
主要终点
Plasma proteomic biomarkers

研究概览

简要总结

We will identify plasma proteomics biomarkers for early diagnosis of lung cancer.

详细描述

We will use TMT-based proteomics approaches to analyze more than 2000 proteins in plasma samples from lung cancer patients and controls. Artificial intelligent (AI) assisted proteomics classifier will be developed for early diagnosis of lung cancer.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • CT screening results showed that the size of pulmonary nodules was more than 5mm
  • No treatment related to pulmonary nodules/lung cancer (including surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy, etc.)
  • Complete clinical and imaging data
  • Chest CT/ low-dose spiral CT reports can be provided in the last 3 months
  • Voluntarily sign informed consent

排除标准

  • There is a history of tumor
  • Clinically uncontrolled active infections, such as acute pneumonia, tuberculosis, etc.
  • Received any treatment related to pulmonary nodules, such as antibiotics and hormones, in the past 4 weeks
  • Complicated with other tumors and serious diseases of the heart, liver, kidney, brain, blood and other systems
  • Participated in other clinical trials within the last 3 months
  • Combined with liver and kidney insufficiency, hypoproteinemia and other diseases affecting protein content
  • You are pregnant or breastfeeding

结局指标

主要结局

Plasma proteomic biomarkers

时间窗: 1 month after surgery

Plasma proteomic biomarkers for detection of lung cancer

Model or classifier performance

时间窗: 1 month after surgery

Artificial intelligent (AI) assisted proteomics classifier will be developed for early diagnosis of lung cancer; and model or classifier performance including AUC, sensitivity, specificity, and accuracy

次要结局

未报告次要终点

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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