Actively Recruiting
A Novel, One Stop, Affordable, Point of Care and Artificial Intelligence Supported System of Screening, Triage and Treatment Selection for Cervical Cancer and Precancer in Low-to-Middle Income Countries
Led by International Agency for Research on Cancer · Updated on 2026-06-01
3200
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
I
International Agency for Research on Cancer
Lead Sponsor
U
University of California, San Francisco
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Novel, One Stop, Affordable, Point of Care and AI Supported System of Screening, Triage and Treatment Selection for Cervical Cancer in LMICs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- No cervical screening during the previous 3 years
- Between the ages of 25 and 49 years
- Understands and signs a written informed consent form
You will not qualify if you...
- Refusal to take part for any reason
- Actively menstruating or pregnant
- Treated earlier for cervical precancer or cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 3 years after screening
Participants who test positive for HPV undergo colposcopy with cervical imaging and biopsy to detect cervical abnormalities.
1 to 2 visits depending on HPV test results and colposcopy findings
Trial Site Locations
Total: 2 locations
1
University of Cincinnati
Cincinnati, Ohio, United States, 45221
Actively Recruiting
2
University of Zimbabwe
Harare, Zimbabwe, 0002
Actively Recruiting
Research Team
P
Partha Basu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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