Affordable AI-supported system for cervical cancer screening, triage, and treatment selection in women aged 25 to 49 in low- and middle-income countries

What this Trial Is About

Researchers are evaluating a new artificial intelligence AI system designed to improve cervical cancer screening, triage, and treatment decisions, particularly in low- and middle-income countries. This study focuses on detecting high-risk human papillomavirus hr-HPV through infrared spectroscopy of urine samples and interpreting cervical images using AI to identify high-grade precancers and cancers. The project aims to address the high burden of cervical cancer in these regions and support global efforts to eliminate the disease. The study is conducted in two parts over five years. In the first two years, the technology for urine spectroscopy and AI image analysis will be refined using samples and images collected from women in Zimbabwe. The second part will validate the improved AI system by screening 2100 women with the AI-supported urine test and a validated HPV test, comparing their ability to detect cervical precancers and cancers. The AI will also be assessed for its accuracy in determining the cervical transformation zone type to assist treatment decisions. Participants will provide self-collected urine and vaginal samples for HPV testing and undergo cervical imaging and colposcopy if positive for HPV. Cervical biopsies will be taken when abnormalities are detected, and women with lesions will be treated or referred as appropriate. The study will measure the accuracy of AI in detecting cervical disease and transformation zone type compared to expert assessments. Safety, cost analysis, and data management will be overseen by international and local research teams. The study lasts approximately five years from recruitment start with ongoing monitoring and management of participants.

Novel, One Stop, Affordable, Point of Care and AI Supported System of Screening, Triage and Treatment Selection for Cervical Cancer in LMICs