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临床试验/NCT06444373
NCT06444373已完成不适用

Development of an Artificial Intelligence Model in Lung Cancer Screening for the Diagnosis of Lung Nodules and Risk Stratification in Subjects With Occupational and/or Smoking Exposure

Scientific Institute San Raffaele1 个研究点 分布在 1 个国家目标入组 728 人开始时间: 2022年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
728
试验地点
1
主要终点
AIM 1 Pilot deep learning model

研究概览

简要总结

Single-center, non-profit, observational, retrospective study of collection of clinical and amnestic data and images to create, implement and develop a pilot model of an integrated virtual platform.

详细描述

The project we propose is a study whose objective was to develop an artificial intelligence program integrated into a web-based platform for the optimization of the performance of lung cancer screening for the diagnosis of lung nodules and risk stratification in subjects exposed to environmental carcinogens and/or cigarette smoke.

Inclusion criteria:

Age > 50; smokers for at least 20 pack-years (20 cigarillos a day for 20 years) or former heavy smokers if they quit less than 15 years ago; and/or previous professional exposure to asbestos; absence of lung cancer symptoms; who performed lung cancer screening after the year 2000 upon approval of the study by the relevant EC.

研究设计

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

入排标准

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

入选标准

  • Age > 50 years;
  • smokers for at least 20 pack-years (20 cigarettes a day for 20 years) or former heavy smokers if they quit less than 15 years ago;
  • and/or previous professional exposure to asbestos;
  • absence of lung cancer symptoms;
  • who performed lung cancer screening after the year 2000 upon approval of the study by the relevant Etical Committee

排除标准

  • Age < 50 years
  • never smokers
  • lung cancer symptoms

结局指标

主要结局

AIM 1 Pilot deep learning model

时间窗: from enrollment to the end of treatment at 2 years

Development and fine-tuning of a pilot deep learning model for automatic detection and diagnosis of screen-detected nodules for risk stratification in subjects with asbestos exposure as part of a lung cancer screening program in high-risk subjects for exposure to asbestos and smoking on retrospective data.

次要结局

  • AIM 2 Clinical database(from enrollment to the end of treatment at 2 years)

研究者

发起方
Scientific Institute San Raffaele
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giulia Veronesi

Medical Doctor

Scientific Institute San Raffaele

研究点 (1)

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