Cervical cancer screening Cancer
Conditions
Interventions
The new technology will be evaluated in a field trial as a screening device (compared to standard of care HPV test), triaging device for HPV positive women (compared to colposcopy) and a diagnostic de
Sponsors
International Agency For Research On Cancer
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. All consenting women aged between 30 to 59 years of age 2. With no cervical cancer screening in last 3 years (if recruited at screening clinics) 3. With recent abnormal screening test (when recruited at the colposcopy clinics) 4. The centers in India will recruit women eligible and willing to undergo cervical cancer screening in the community and/or hospital outpatients 5. The centers outside India will recruit women at the colposcopy clinics where the women with abnormal screening tests (cytology, HPV test or VIA) are evaluated with colposcopy
Exclusion criteria
Exclusion criteria: 1. Refusal to participate; actively menstruating or pregnant 2. Inability to provide consent due to mental or debilitating illness 3. Previously detected with cervical precancer or cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Accuracy of AI based algorithm in detecting cervical high grade lesion is measured by estimating the specificity and sensitivity with histopathology as gold standard, after all the cases are recruited and investigated 2. The agreement between the investigational device and a colposcopist to correctly identify the transformation zone will be calculated from the data capture from all the study subjects, after all the cases are recruited and investigated | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
India, Thailand
Contacts
Public ContactPartha Basu
Outcome results
None listed