Role of Artificial Intelligence-based colposcope for detection of pre-cancerous and cancerous cervical lesions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 268
- 试验地点
- 1
- 主要终点
- To evaluate the diagnostic accuracy of the Smartscope® for detection of pre-cancerous and cancerous lesions of the cervix using cytology or histopathology as the reference standard
研究概览
简要总结
In India, the most common cancer of the female reproductive tract is cervical cancer. Screening for cervical cancer is an effective way to prevent the morbidity and mortality associated with the disease. WHO recommends regular screening for cervical cancer for every woman above the age of 30 years for early detection of abnormal cells. Smartscope® is an Artifical Intelligence based colposcope is an effective strategy to reduce subjectivity. It is based on the principle of colposcopy and VIA-VILI examination allowing a magnified view of the cervix and vaginal colpos as well as an objective assessment of the images of the examination through artificial intelligence. A PAP smear for all sexually active women above the age of 30 will be taken following which Pre and Post VIA-VILI images will be captured using the smartscope and the results will be analyzed for the need of biopsy in case of abnormal findings in either of the two. The results will be compared with the cytology and histopathology using the latter as the reference standard.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Sexually active women above the age of 30 (as recommended by WHO guidelines 2021).
排除标准
- •Type 3 squamocolumnar junction Active bleeding per vaginum Frank growth on the cervix Post hysterectomy History of treatment of cancerous lesions Acute cervical infection or pelvic inflammatory disease (patients can be included after treatment).
结局指标
主要结局
To evaluate the diagnostic accuracy of the Smartscope® for detection of pre-cancerous and cancerous lesions of the cervix using cytology or histopathology as the reference standard
时间窗: At first visit (when smartscope used), on collection of Pap report ,on collection of cervical biopsy report
次要结局
- To compare the Swede score calculated by the observer with the AI-based diagnosis keeping cytology and histopathology as the reference standard(At first visit (when smartscope used), on collection of Pap report ,on collection of cervical biopsy report)