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临床试验/NCT04551287
NCT04551287已完成不适用

Artificial Intelligence Enables Precision Diagnosis of Cervical Cytology Grades and Cervical Cancer

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University3 个研究点 分布在 1 个国家目标入组 16,164 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16,164
试验地点
3
主要终点
Area under ROC curve (AUC)

研究概览

简要总结

Cervical cancer, the fourth most common cancer globally and the fourth leading cause of cancer-related deaths, can be effectively prevented through early screening. Detecting precancerous cervical lesions and halting their progression in a timely manner is crucial. However, accurate screening platforms for early detection of cervical cancer are needed. Therefore, it is urgent to develop an Artificial Intelligence Cervical Cancer Screening (AICS) system for diagnosing cervical cytology grades and cancer.

研究设计

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

入排标准

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

入选标准

  • Women Aged 25-65 years old.
  • Availability of confirmed diagnostic results of the cervical liquid-based cytological examination, and satisfactory digital images from the liquid-based cytology pap test: at least 5000 uncovered and observable squamous epithelial cells, samples with abnormal cells (atypical squamous cells or atypical glandular cells and above).

排除标准

  • Unsatisfactory samples of cervical liquid-based cytological examination: less than 5000 uncovered, observable squamous epithelial cells, and more than 75% of squamous epithelial cells affected because of blood, inflammatory cells, epithelial cells over-overlapping, poor fixation, excessive drying, or contamination of unknown components.
  • Women diagnosed with other malignant tumors other than cervical cancer.

结局指标

主要结局

Area under ROC curve (AUC)

时间窗: Diagnostic evaluation will be performed within 1 week when the smear pictures are obtained

Area under the curve

次要结局

  • Specificity(Diagnostic evaluation will be performed within 1 week when the smear pictures are obtained)
  • Accuracy(Diagnostic evaluation will be performed within 1 week when the smear pictures are obtained)
  • Sensitivity(Diagnostic evaluation will be performed within 1 week when the smear pictures are obtained)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Herui Yao

Principal Investigator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

研究点 (3)

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