PRIORITY Study in Cervical Cancer

NCT07593066 | Not Yet Recruiting

• 2 other identifiers: UC-CCU-PRIORITY-2026FNC-2025-1440
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 8

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.

Conditions

Cervical Cancer; HPV Infection; Cervical Intraepithelial Neoplasia

Keywords

HPV self-sampling; Digital colposcopy; Telemedicine; Diagnostic prioritization; Cervical cancer screening

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of the integrated molecular and digital model for detection of CIN2+

  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 Outcomes (5)

• Concordance between self-collected and clinician-collected samples for high-risk HPV and extended molecular panel detection

  Baseline

• Prevalence of sexually transmitted infections and vaginal dysbiosis markers detected by extended molecular screening

  Baseline

• Prevalence ratio of high-risk HPV positivity in participants with sexually transmitted infections detected by extended molecular screening

  Up to 6 months

• Odds ratio for histologically confirmed CIN2+ in participants with sexually transmitted infections detected by extended molecular screening

  Up to 6 months

• Time to diagnostic resolution

  Up to 6 months

Other Outcomes (4)

• Participant-Reported Acceptability Score Using the Self-Sampling and Telemedicine Diagnostic Pathway Acceptability Questionnaire

  Up to 6 months

• Direct transportation costs associated with the diagnostic pathway

  Up to 6 months

• Productive Activity Days Lost Associated With the Diagnostic Pathway

  Up to 6 months

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (8)

Hospital regional de Coyhaique

Coyhaique, Aysén, 5951801, Chile

Location

Hospital San Pablo

Coquimbo, Coquimbo Region, 1781881, Chile

Location

Hospital de Talca

Talca, Maule Region, 3460001, Chile

Location

San Jorge Medical Center UC-Christus Health Network

Santiago, Metropolitan Region, 7580153, Chile

Location

San Joaquín Medical Center, UCChristus Health Network

Santiago, Metropolitan Region, 7820436, Chile

Location

Ancora San Francisco Medical Center UC Christus Health Network

Santiago, Metropolitan Region, 8150031, Chile

Location

Cancer Centre UC-Christus Nuestra Sra de la Esperanza

Santiago, Metropolitan Region, 8330032, Chile

Location

Santa Lucia Medical Center UC-Christus Health Network

Santiago, Metropolitan Region, 8331010, Chile

Location

Related Links

• Department of Obstetrics and Gynecology, Pontificia Universidad Católica de Chile

Biospecimen

Retention: SAMPLES WITH DNA

Cervical self-collected samples for high-risk human papillomavirus (HPV) testing and clinician-collected cervical samples obtained during digital colposcopy, processed for molecular analysis. Samples are used for diagnostic purposes and are not stored long-term.

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Cervical Dysplasia; Papillomavirus Infections

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Precancerous Conditions; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mauricio A Cuello, MD

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mauricio A Cuello, MD

CONTACT

+56223543034; mcuello@uc.cl

Nicolás Saez, MD

CONTACT

+56223543034; nsaez@ucchristus.cl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.

Locations

CL (8)