PRIORITY Study in Cervical Cancer

Overview

The PRIORITY study is a prospective, multicenter observational study designed to evaluate an integrated diagnostic model combining extended molecular self-sampling and digital colposcopy supported by telemedicine for the prioritization of women at risk of cervical cancer. The study aims to assess the diagnostic performance, concordance, and clinical utility of this integrated approach in real-world settings, as well as its impact on diagnostic timeliness and patient navigation across different levels of care. Participants will undergo standard-of-care evaluation, and data will be collected on molecular test results, colposcopic findings, diagnostic outcomes, and time intervals within the care pathway. No interventions are assigned as part of the study protocol. The findings are expected to inform scalable strategies to improve early detection and optimize diagnostic pathways for cervical cancer, particularly in settings with structural and geographic barriers to timely care.

The PRIORITY study is a prospective, multicenter observational study designed to evaluate an integrated diagnostic model for cervical cancer that combines extended high-risk human papillomavirus (HPV) self-sampling, digital colposcopy, and telemedicine-based prioritization. The study will be conducted across multiple healthcare centers in Chile, including primary care and referral centers, reflecting real-world clinical pathways. Participants will be women undergoing evaluation for cervical cancer screening or diagnostic follow-up according to standard clinical practice. No interventions are assigned as part of the study protocol. Data will be collected prospectively and will include results from molecular HPV testing, digital colposcopic assessments, and histopathological findings when available. Additional variables will include time intervals across the diagnostic pathway, including time from screening to diagnostic confirmation, as well as healthcare system navigation indicators. The primary objective is to assess the diagnostic performance and concordance between molecular testing and colposcopic findings. Secondary objectives include evaluation of diagnostic timeliness, feasibility of implementing the integrated model, and patient-reported experience measures. This study is designed to generate real-world evidence on the potential of integrated diagnostic strategies to improve prioritization and reduce delays in cervical cancer detection, particularly in settings with structural and geographic barriers to timely care.