Using AI to Diagnose Cervical Lesions from Colposcopy Images
Multi-center Application of an Artificial Intelligence System for Automatic Real-time Diagnosis of Cervical Lesions Based on Colposcopy Images
This study is testing whether an AI system can better diagnose cervical lesions from colposcopy images compared to doctors of different experience levels, and it involves 10,000 women in Fujian Province, China.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fujian Maternity and Child Health Hospital Academic / other |
| Locations | 5 sites (Fuzhou, Fujian and 4 other locations) |
| Trial ID | NCT05281939 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and validate a multimodal artificial intelligence diagnostic system that analyzes colposcopy images alongside other medical data, such as HPV test results and cytology. Conducted across multiple centers in Fujian Province, China, it will enroll 10,000 women who have undergone colposcopy examinations. The study will compare the diagnostic accuracy of the AI system with that of traditional physicians at various experience levels. By leveraging a large database of cervical lesion images and related data, the research seeks to enhance the accuracy of cervical lesion diagnoses.
Who should consider this trial
Good fit: Ideal candidates for this study are married women aged 18 and over with abnormal results from cervical cancer screening.
Not a fit: Patients with acute reproductive tract inflammation, a history of pelvic radiotherapy, mental disorders, or other malignant tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this AI diagnostic system could significantly improve the accuracy and efficiency of cervical lesion diagnosis, leading to better patient outcomes.
How similar studies have performed: Other studies have shown promise in using AI for medical image analysis, suggesting that this approach could be effective, though this specific application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Fuzhou, Fujian and 4 other locations
- Fujian Maternity and Child Health Hospital — Fuzhou, Fujian, China (Recruiting)
- Mindong Hospital of Ningde City — Ningde, Fujian, China (Recruiting)
- Jianou Maternal and child Health Care Hospital — Nanping, China (Recruiting)
- Ningde Hospital affiliated to Ningde Normal University — Ningde, China (Recruiting)
- Quanzhou First Hospital — Quanzhou, China (Recruiting)
Study contacts
- Study coordinator: Binhua Dong
- Email: dbh18-jy@126.com
- Phone: +8613599071900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.