Validation of a Lab-free Low-cost Screening Test for Prevention of Cervical Cancer: Automated Visual Evaluation
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Other, Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this study is to validate Automated Visual Evaluation (AVE), specifically the CINFinder version developed by DL Analytics, a point-of-care screening and triage diagnostic tool for cervical cancer based on the assessment of digital images through artificial intelligence. Several teams around the world have developed versions of AVE as a triage technology but none as a screening tool.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 30
Maximum Age: 59
Healthy Volunteers: t
View:
• Women between 30 and 59 years of age
Locations
Other Locations
El Salvador
Ministerio de Salud
RECRUITING
San Salvador
Contact Information
Primary
David Levitz, PhD
levitz@dlanalytics.ai
817-966-5600
Time Frame
Start Date: 2025-02-12
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 10000
Treatments
Experimental: Experimental
Women eligible for HPV screening based on El Salvador's national guidelines will receive careHPV, VIA, and AVE (active comparator).~Screen-positive women by HPV, VIA or AVE referred to colposcopy clinic and 5% of screen-negative women (negative on HPV, VIA, and AVE).~Cervical cancer triage and diagnostic tests among screen- positive women and screen negative women.~Biopsy-confirmed positive will receive necessary treatment by local standard of care.
Related Therapeutic Areas
Sponsors
Leads: DL Analytics
Collaborators: National Cancer Institute (NCI), Basic Health International, Inc.