Cervical Cancer, Cervical Intraepithelial Neoplasia, HPV Infection
Conditions
Keywords
HPV self-sampling, Digital colposcopy, Telemedicine, Diagnostic prioritization, Cervical cancer screening
Brief summary
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.
Interventions
None listed
Sponsors
Pontificia Universidad Catolica de Chile
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of the integrated molecular and digital model for detection of CIN2+ | Up to 6 months | Sensitivity, specificity, positive predictive value, and negative predictive value of the combined strategy including extended molecular self-sampling, clinician-collected sampling, and digital colposcopy for detecting histologically confirmed cervical intraepithelial neoplasia grade 2 or worse (CIN2+). Measure reported: sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to diagnostic resolution | Up to 6 months | Time from initial molecular self-sampling to diagnostic resolution, defined as histological confirmation when clinically indicated or completion of diagnostic evaluation according to standard care. Measure reported: days from initial molecular self-sampling to diagnostic resolution. |
| Concordance between self-collected and clinician-collected samples for high-risk HPV and extended molecular panel detection | Baseline | Agreement between vaginal self-sampling and clinician-collected cervical samples for detection of high-risk HPV genotypes and extended molecular findings, assessed using Cohen's kappa and percent agreement. Measure reported: Cohen's kappa coefficient and percent agreement. |
| Prevalence of sexually transmitted infections and vaginal dysbiosis markers detected by extended molecular screening | Baseline | Prevalence of sexually transmitted infections and vaginal dysbiosis markers detected through the extended molecular panel, including Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, Trichomonas vaginalis, bacterial vaginosis-associated markers, Candida species, and genital ulcer pathogens. Measure reported: Prevalence (%) of sexually transmitted infections and vaginal dysbiosis markers detected through extended molecular screening. |
| Prevalence ratio of high-risk HPV positivity in participants with sexually transmitted infections detected by extended molecular screening | Up to 6 months | Prevalence ratio of high-risk HPV positivity among participants with sexually transmitted infections detected using the extended molecular screening panel. High-risk HPV positivity will be defined as the proportion (%) of participants with a positive validated molecular HPV test. Measure reported: Prevalence ratio (PR) with 95% confidence intervals. |
| Odds ratio for histologically confirmed CIN2+ in participants with sexually transmitted infections detected by extended molecular screening | Up to 6 months | Odds ratio for histologically confirmed cervical intraepithelial neoplasia grade 2 or worse (CIN2+) among participants with sexually transmitted infections detected using the extended molecular screening panel. CIN2+ will be defined as the proportion (%) of participants with histologically confirmed cervical intraepithelial neoplasia grade 2 or worse. Measure reported: Odds ratio (OR) with 95% confidence intervals. |
Countries
Chile
Contacts
CONTACTMauricio A Cuello, MD
CONTACTNicolás Saez, MD
PRINCIPAL_INVESTIGATORMauricio A Cuello, MD
Pontificia Universidad Catolica de Chile
Outcome results
None listed