PRIORITY Study in Cervical Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cervical Cancer, Cervical Intraepithelial Neoplasia, HPV Infection. Basic parameters: 30 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Chile
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The PRIORITY Study in Cervical Cancer: A Prospective Multicenter Observational Evaluation of an Integrated Molecular and Digital Model for Diagnostic Prioritization
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.
Detailed description
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.
Primary outcome measures
- Diagnostic accuracy of the integrated molecular and digital model for detection of CIN2+ [Time frame: Up to 6 months]
Secondary outcome measures (5)
- Concordance between self-collected and clinician-collected samples for high-risk HPV and extended molecular panel detection [Time frame: Baseline]
- Prevalence of sexually transmitted infections and vaginal dysbiosis markers detected by extended molecular screening [Time frame: Baseline]
- Prevalence ratio of high-risk HPV positivity in participants with sexually transmitted infections detected by extended molecular screening [Time frame: Up to 6 months]
- Odds ratio for histologically confirmed CIN2+ in participants with sexually transmitted infections detected by extended molecular screening [Time frame: Up to 6 months]
- Time to diagnostic resolution [Time frame: Up to 6 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Chile · 8 centers
- Hospital regional de Coyhaique — Coyhaique
- Hospital San Pablo — Coquimbo
- Hospital de Talca — Talca
- San Jorge Medical Center UC-Christus Health Network — Santiago
- San Joaquín Medical Center, UCChristus Health Network — Santiago
- Ancora San Francisco Medical Center UC Christus Health Network — Santiago
- Cancer Centre UC-Christus Nuestra Sra de la Esperanza — Santiago
- Santa Lucia Medical Center UC-Christus Health Network — Santiago
Identifiers
NCT: NCT07593066 · UC-CCU-PRIORITY-2026 · FNC-2025-1440