PredAID-CERVIA: AI based Cervical Cancer Screening
Not Applicable
- Registration Number
- CTRI/2022/05/042719
- Lead Sponsor
- BlockAppsAI Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1)Women aged between 25 and 65 years of age, inclusive.
2)Participants should have a history of sexual activity.
Exclusion Criteria
1)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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.Timepoint: 9 Months
- Secondary Outcome Measures
Name Time Method Secondary outcome: Measure of the subjects experience, and opinion of the VIA procedure based on the following criteria â?? 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 basisTimepoint: Same time point as the primary outcome