The development and evaluation of an artificial intelligence (AI) image recognition device to improve cervical pre-cancer screening and management in low- and middle-income countries

Phase 2

• Conditions: Cervical cancer screening; Cancer

• Registration Number: ISRCTN18333554
• Lead Sponsor: International Agency For Research On Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-04
• Last Update Posted: 26 September 2023
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 5040

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified