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临床试验/NCT05281939
NCT05281939招募中不适用

Multi-center Application of an Artificial Intelligence System for Automatic Real-time Diagnosis of Cervical Lesions Based on Colposcopy Images

Fujian Maternity and Child Health Hospital5 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10,000
试验地点
5
主要终点
Accuracy of CIN3+ diagnosis

研究概览

简要总结

The application of artificial intelligence in image recognition of cervical lesions diagnosis has become a research hotspot in recent years. The analysis and interpretation of colposcopy images play an important role in the diagnosis,prevention and treatment of cervical precancerous lesions and cervical cancer. At present, the accuracy of colposcopy detection is still affected by many factors. The research on the diagnosis system of cervical lesions based on multimodal deep learning of colposcopy images is a new and significant research topic. Based on the large database of cervical lesions diagnosis images and non-images, the research group established a multi-source heterogeneous cervical lesion diagnosis big data platform of non-image and image data. Research the lesions segmentation and classification model of colposcopy image based on convolutional neural network, explore the relevant medical data fusion network model that affects the diagnosis of cervical lesions, and realize a multi-modal self-learning artificial intelligence cervical lesion diagnosis system based on colposcopy images. The application efficiency of the artificial intelligence system in the real world was explored through the cohort, and the intelligent teaching model and method of cervical lesion diagnosis were further established based on the above intelligent system.

详细描述

Based on previous studies and clinical practice, this study carried out a multi center application in Fujian Province, China. In this study, Fujian Maternity and Child Health Hospital and Mindong Hospital of Ningde City were included, with a total of 10000 participants who have undergone colposcopy examination were enrolled. In the first place, the investigators will build a multimodal artificial intelligence diagnostic system by combining colposcopy images with other non-image data, such as the results of HPV tests and Thinprep cytologic test (TCT) and so on. And then, use standardized colposcopy images and non-image medical data of cervical lesions in different medical institutions to verify the efficacy of the multimodal intelligent diagnostic system for cervical lesions. What's, more, the investigators will establish artificial intelligence cohorts (assisted by intelligent systems) and traditional physician cohorts (assisted by expert, senior and primary physicians) to contrast the diagnosis results of the multimodal artificial intelligence diagnostic system and different levels of colposcopy doctors. And can also bidirectionally analyse the diagnostic efficacy and differences of the system and colposcopy physicians of different levels, and evaluate the performance of this diagnostic system for real-world applications.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Masking was performed for all participants, colposcopists, and outcome assessor.

入排标准

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

入选标准

  • Married woman
  • Woman aged 18 and over
  • Woman with an intact cervix
  • Patients with abnormal results in cervical cancer screening
  • Be able to understand this study and have signed a written informed consent

排除标准

  • Woman with acute reproductive tract inflammation
  • History of pelvic radiotherapy surgery
  • Woman with mental disorder
  • Patients with history of other malignant tumors
  • Refuse to participate in this study

结局指标

主要结局

Accuracy of CIN3+ diagnosis

时间窗: 0 month

Accuracy in the diagnosis of cervical intraepithelial neoplasia grade 3 or worse.

HPV testing

时间窗: o month

Cervical exfoliated cells were collected for HPV testing

Accuracy of CIN2+ diagnosis

时间窗: 0 month

Accuracy in the diagnosis of cervical intraepithelial neoplasia grade 2 or worse.

Cervical cytology testing

时间窗: 0 month

Cervical exfoliated cells were collected for cytological and pathological examination.

Cervical histopathological examination

时间窗: 0 month

Cervical tissue was collected for histopathological examination

次要结局

未报告次要终点

研究者

发起方
Fujian Maternity and Child Health Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Binhua Dong

Principal Investigator

Fujian Maternity and Child Health Hospital

研究点 (5)

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