Evaluation ofsmartphone based Artificial Intelligence (AI) - imaging system forscreening of cervical cancer in female sex workers - A prospectiveobservational study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 25.00 Year(s) to 65.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Women female Sex Workers aged between 25 and 65 years of age, inclusive.
- •Participants should have a history of sexual activity.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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.
Time Frame: 9 Months
Secondary Outcomes
- 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.)