Validation of a Low-cost, Lab-free AI Screening Test for Cervical Cancer Prevention Using Automated Visual Evaluation CINFinder

What this Trial Is About

Researchers are evaluating Automated Visual Evaluation AVE, specifically the CINFinder version developed by DL Analytics, as a new low-cost, lab-free screening and triage tool for cervical cancer. This study focuses on women in El Salvador, where cervical cancer remains a leading cause of female cancer death due to persistent HPV infection and limited screening resources. The trial compares the sensitivity of AVE against traditional methods like HPV testing and visual inspection with acetic acid VIA. Histopathology diagnosis will be used as the reference standard to confirm disease status. The study involves 10,000 women aged 30 to 59 years undergoing screening visits where HPV samples, VIA, and AVE assessments are performed using the EVA System digital colposcope and an Android smartphone. Women testing positive on any screening test are referred for colposcopy with biopsy, while 5% of screen-negative women also undergo this procedure. Results from the AVE and VIA tests at screening and colposcopy visits will be compared to determine AVEs accuracy as both a screening and triage method. Those diagnosed with precancerous lesions may receive thermal ablation or LEEP treatment according to local standards. Participants will attend up to three visits screening, colposcopy with biopsy, and result delivery with possible treatment. Clinical data, images, and test results are recorded on paper or electronic forms and managed securely with specialized software. The primary outcomes include AVEs sensitivity and positive predictive value for detecting high-grade cervical precancer CIN2 within 12 months. The study includes ongoing follow-up and data verification to assess the new technologys performance in a low-resource setting.

Validation of a Lab-free Low-cost Screening Test for Prevention of Cervical Cancer