Clinical trial NCT05281939: Multi-center Application of an AI System for Diagnosis of Cervical Lesions Based on Colposcopy Images
Official title: Multi-center Application of an Artificial Intelligence System for Automatic Real-time Diagnosis of Cervical Lesions Based on Colposcopy Images
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Artificial Intelligence
Colposcopy
Cervical Lesions
Image
Lead sponsor: Fujian Maternity and Child Health Hospital
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomly assigned to an Artificial intelligence (AI) group or a control group.
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: HPV testing
timeFrame: o month
measure: Cervical cytology testing
timeFrame: 0 month
measure: Cervical histopathological examination
timeFrame: 0 month
measure: Accuracy of CIN2+ diagnosis
timeFrame: 0 month
measure: Accuracy of CIN3+ diagnosis
timeFrame: 0 month
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Maternity and Child Health Hospital
state: Fujian
city: Ningde
country: China
facility: Mindong Hospital of Ningde City
state: Fujian
city: Nanping
country: China
facility: Jianou Maternal and child Health Care Hospital
city: Ningde
country: China
facility: Ningde Hospital affiliated to Ningde Normal University
city: Quanzhou
country: China
facility: Quanzhou First Hospital
Study officials:
affiliation: Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University
name: Pengming Sun, PhD
role: STUDY_CHAIR
References: