About this trial
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.
Eligibility criteria
Qualifiers
Women aged 30 to 65 years
Eligible for cervical cancer screening according to national guidelines
Able and willing to provide informed consent
Able to perform self-sampling or attend clinical evaluation if required
Disqualifiers
Previous diagnosis of cervical cancer
History of total hysterectomy (removal of the cervix)
Current pregnancy if it precludes study procedures according to clinical judgment
Any medical or social condition that, in the opinion of the investigators, would interfere with participation or follow-up
Trial design
Treatments tested in this trial
- Not listed