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临床试验/NCT06786793
NCT06786793招募中不适用

Artificial Intelligence in Endoscopic Diagnosis of Colorectal Polyps: A Prospective Randomized Study.

Jagiellonian University4 个研究点 分布在 1 个国家目标入组 630 人开始时间: 2024年11月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
630
试验地点
4
主要终点
Adenoma detection rate (ADR)

研究概览

简要总结

Colorectal cancer is the second most common malignancy in the countries of the European Union. Colonoscopy is the primary method for detecting and preventing the development of colorectal cancer is endoscopic examination. This study aims to evaluate the impact of artificial intelligence on the detection rate of polyps and early stages of colorectal cancer.

详细描述

Colorectal cancer is the second most common malignancy in the countries of the European Union. The primary method for detecting and preventing the development of colorectal cancer is endoscopic examination-colonoscopy, during which precancerous lesions such as adenomas and serrated polyps can be removed. The effectiveness of colonoscopy depends on the adenoma detection rate, which varies among endoscopists and is influenced by their skills and experience. It has been proven that high-quality colonoscopy prevents the omission of colorectal cancer, which might develop in the future as so-called interval cancer. A breakthrough in machine learning in recent years has enabled the development of commercial artificial intelligence systems. These systems aim to improve the detection rates of precancerous polyps and, consequently, potentially reduce the risk of developing colorectal cancer. Artificial intelligence is also expected to help standardize performance across endoscopic procedures of varying quality, thereby contributing to a reduction in colorectal cancer incidence in the future. This study aims to evaluate the impact of artificial intelligence on the detection rate of polyps and early stages of colorectal cancer.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
50 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Consent to participate in the study,
  • Age between 50 and 65 years,
  • Scheduled outpatient colonoscopy.

排除标准

  • Previous colonoscopy,
  • History of colorectal surgery,
  • Ongoing biological therapy for any indication,
  • Primary sclerosing cholangitis,
  • Familial polyposis syndrome,
  • Chronic diarrhea,
  • Ulcerative colitis,
  • Crohn's disease.

结局指标

主要结局

Adenoma detection rate (ADR)

时间窗: During the colonoscopy examination

The percentage of colonoscopies when at least one histologically proven adenoma was found.

次要结局

  • Utility of artificial intelligence for both novice and experienced endoscopists(During the colonoscopy examination)
  • Assessing the morphology of polyps detected during colonoscopy(During the colonoscopy examination)
  • Cost analysis of procedures performed with the use of artificial intelligence(Through study completion, an average of 6 months)

研究者

发起方
Jagiellonian University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zofia Orzeszko

Principal Investigator

Jagiellonian University

研究点 (4)

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