PRIORITY Study in Cervical Cancer (PRIORITY)

May 11, 2026 updated by: Pontificia Universidad Catolica de Chile

The PRIORITY Study in Cervical Cancer: A Prospective Multicenter Observational Evaluation of an Integrated Molecular and Digital Model for Diagnostic Prioritization

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mauricio A Cuello, MD
  • Phone Number: +56223543034
  • Email: mcuello@uc.cl

Study Contact Backup

Study Locations

  • Chile
    • Aysén
      • Coyhaique, Aysén, Chile, 5951801
        • Hospital regional de Coyhaique
        • Contact:
          • Mauricio A Cuello, MD
          • Phone Number: +56223543034
          • Email: mcuello@uc.cl
        • Contact:
        • Principal Investigator:
          • Pablo Mardones, MD
    • Coquimbo Region
      • Coquimbo, Coquimbo Region, Chile, 1781881
        • Hospital San Pablo
        • Contact:
          • Mauricio A Cuello, MD
          • Phone Number: +56223543034
          • Email: mcuello@uc.cl
        • Contact:
        • Principal Investigator:
          • Pablo Avalos, MD
    • Maule Region
      • Talca, Maule Region, Chile, 3460001
        • Hospital de Talca
        • Contact:
          • Mauricio A Cuello, MD
          • Phone Number: +56223543034
          • Email: mcuello@uc.cl
        • Contact:
        • Principal Investigator:
          • Yesica Sagredo, MD
    • Metropolitan Region
      • Santiago, Metropolitan Region, Chile, 7580153
        • San Jorge Medical Center UC-Christus Health Network
        • Contact:
        • Contact:
          • Mauricio A Cuello, MD
          • Phone Number: +56982391249
          • Email: mcuello@uc.cl
        • Principal Investigator:
          • Nicolas Saez, MD
        • Sub-Investigator:
          • Mauricio A Cuello, MD
      • Santiago, Metropolitan Region, Chile, 7820436
        • San Joaquín Medical Center, UCChristus Health Network
        • Contact:
          • Mauricio A Cuello, MD
          • Phone Number: +56982391249
          • Email: mcuello@uc.cl
        • Principal Investigator:
          • Nicolas Saez, MD
        • Contact:
      • Santiago, Metropolitan Region, Chile, 8150031
        • Ancora San Francisco Medical Center UC Christus Health Network
        • Contact:
          • Mauricio A Cuello, MD
          • Phone Number: +56982391249
          • Email: mcuello@uc.cl
        • Principal Investigator:
          • Nicolas Saez, MD
        • Contact:
      • Santiago, Metropolitan Region, Chile, 8330032
        • Cancer Centre UC-Christus Nuestra Sra de la Esperanza
        • Contact:
          • Mauricio A Cuello, MD
          • Phone Number: +56982391249
          • Email: mcuello@uc.cl
        • Contact:
        • Principal Investigator:
          • Mauricio A Cuello, MD
        • Sub-Investigator:
          • Nicolas Saez, MD
      • Santiago, Metropolitan Region, Chile, 8331010
        • Santa Lucia Medical Center UC-Christus Health Network
        • Contact:
          • Mauricio A Cuello, MD
          • Phone Number: +56982391249
          • Email: mcuello@uc.cl
        • Principal Investigator:
          • Nicolas Saez, MD
        • Sub-Investigator:
          • Mauricio A Cuello, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Women aged 30 to 65 years participating in cervical cancer screening programs in participating centers, including both urban and underserved populations. The study aims to reflect real-world conditions, including variability in access to care, geographic barriers, and healthcare system navigation.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of the integrated molecular and digital model for detection of CIN2+
Time Frame: 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).
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance between self-collected and clinician-collected samples for high-risk HPV and extended molecular panel detection
Time Frame: 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.
Baseline
Prevalence of sexually transmitted infections and vaginal dysbiosis markers detected by extended molecular screening
Time Frame: 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.
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

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.
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

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.
Up to 6 months
Time to diagnostic resolution
Time Frame: 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.
Up to 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant-Reported Acceptability Score Using the Self-Sampling and Telemedicine Diagnostic Pathway Acceptability Questionnaire
Time Frame: Up to 6 months

Participant-reported acceptability will be assessed using the investigator-developed Self-Sampling and Telemedicine Diagnostic Pathway Acceptability Questionnaire, a structured 5-item questionnaire evaluating ease of self-sampling, confidence in performing the procedure, understanding of instructions, comfort with digital colposcopy, and satisfaction with telemedicine-supported follow-up. Each item is scored on a 5-point Likert scale from 1 to 5. A composite score will be calculated by summing all item responses. Scores range from 5 to 25 points, with higher scores indicating greater acceptability.

Measure reported: Composite acceptability score (range 5-25 points; higher scores indicate greater acceptability).
Up to 6 months
Direct transportation costs associated with the diagnostic pathway
Time Frame: Up to 6 months

Participant-reported transportation expenses associated with screening, diagnostic evaluation, referral visits, and follow-up care will be assessed using an investigator-developed healthcare utilization and cost questionnaire. Total transportation costs will be calculated as the cumulative sum of all transportation-related expenses incurred throughout the diagnostic pathway.

Measure reported: Total transportation cost in Chilean pesos (CLP).
Up to 6 months
Productive Activity Days Lost Associated With the Diagnostic Pathway
Time Frame: Up to 6 months

Number of participant-reported productive activity days lost throughout the diagnostic pathway, assessed as a single cumulative count variable.

Measure reported: Total number of productive activity days lost.
Up to 6 months
Indirect non-medical expenses associated with the diagnostic pathway
Time Frame: Up to 6 months

Participant-reported indirect non-medical expenses incurred during the diagnostic process will be assessed using an investigator-developed healthcare utilization and cost questionnaire. Total indirect non-medical expenses will be calculated as the cumulative sum of eligible participant-reported expenses.

Measure reported: Total indirect non-medical expenses in Chilean pesos (CLP).
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Investigators

  • Principal Investigator: Mauricio A Cuello, MD, Pontificia Universidad Católica de Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 30, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 29, 2026

First Submitted That Met QC Criteria

May 11, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UC-CCU-PRIORITY-2026
  • FNC-2025-1440 (Other Grant/Funding Number: Ministry of Health of Chile (National Cancer Fund))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) including clinical, molecular, imaging (colposcopy), and patient-reported outcomes collected during the study will be available.

Data will be shared after publication of the primary results, upon reasonable request, and subject to approval by the study investigators and the corresponding ethics committee.

All shared data will be fully anonymized and will not include any direct or indirect identifiers.

Data access will be granted for scientifically sound proposals, with a signed data access agreement, and in compliance with Chilean data protection laws (Law 19.628) and institutional policies.

No identifiable data will be shared under any circumstances.

IPD Sharing Time Frame

De-identified individual participant data and supporting documents will be available beginning 6 months after publication of the primary results and will remain available for at least 5 years.

Access will be provided upon reasonable request to the study investigators and subject to approval by the corresponding ethics committee.

IPD Sharing Access Criteria

Access to de-identified data will be granted to researchers who provide a methodologically sound proposal.

Requests will be reviewed by the study investigators and must receive approval from the corresponding ethics committee.

A data use agreement will be required, ensuring compliance with institutional policies and Chilean data protection regulations (Law 19.628).

No identifiable data will be shared under any circumstances.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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