Evaluation ofsmartphone based Artificial Intelligence (AI) - imaging system forscreening of cervical cancer in female sex workers - A prospectiveobservational study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Specificity, sensitivity, PPV and NPV of prediction of VIA classes, namely, "Positive", "Negative" or "Suspicious for Cancer" by PredAID-CerVIA and a group of experienced gynecologists (Human Expert Group), taking a combination of conventional cytology (Pap smear) and physicians verdict as reference.
研究概览
简要总结
Cervical cancer mortality can be largely prevented by early detection of the disease through screening programs. Countries that have properly implemented Pap-smear or HPV DNA tests as screening modalities have seen a significant drop in cervical cancer-related mortality. However, Pap-smear or HPV DNA testing is not suitable for developing countries such as India. Alternatives, such as Visual Inspection by Acetic Acid (VIA) and Visual Inspection by Lugol’s Iodine (VILI) are highly suited to low-resource settings but have significant barriers to scaling – due to variability inherent in manual assessment. In this scenario, technologies such as Artificial Intelligence, Computer Vision, and mobile photography offer the possibility of creating robust, low-cost, scalable, and sustainable solutions for the mass screening of cervical cancer. The proposed study seeks to evaluate the sensitivity, specificity, Positive Predictive Value, and Negative Predictive Value of PredAID-CVIA – a smartphone-based, AI-solution for assessment of VIA for women in Tertiary care center at LMH Nagpur, and compare its performance against human experts.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 25.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women female Sex Workers aged between 25 and 65 years of age, inclusive.
- •Participants should have a history of sexual activity.
排除标准
- •Menstruating women 2)Pregnant women women who have had childbirth with 6 weeks prior to the date of test 3)Women who have had hysterectomy 4)Women who have vaginal infections, discharge etc.
- •at the time of the test.
结局指标
主要结局
Specificity, sensitivity, PPV and NPV of prediction of VIA classes, namely, "Positive", "Negative" or "Suspicious for Cancer" by PredAID-CerVIA and a group of experienced gynecologists (Human Expert Group), taking a combination of conventional cytology (Pap smear) and physicians verdict as reference.
时间窗: 9 Months
次要结局
- Secondary outcome: Measure of the subjects experience, and opinion of the VIA procedure based on the following criteria – level of comfort, level of comfort with smartphone camera-based image acquisition the likelihood of repeating the test on a yearly two-yearly or five-yearly basis(Data Gathering for secondary outcone happens in the same timelines as that of the primary outcome. In this case its 9 months.)