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Cervical CancerPRIORITYNCT07593066

PRIORITY Study in Cervical Cancer

An observational study of Cervical Cancer and Cervical Intraepithelial Neoplasia, run by Pontificia Universidad Catolica de Chile at 8 sites in Chile.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 65 years, women onlyHealthy volunteers can take part
How many people
700 participants
Where
8 sitesChile
Study dates
30 Jun 2026to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Mauricio A Cuello, MD contact

+56223543034

mcuello@uc.cl

Nicolás Saez, MD contact

+56223543034

nsaez@ucchristus.cl

8 sites in 1 country

Chile8 sites

  • Hospital San Pablo

    Coquimbo, Coquimbo Region, 1781881

    Pablo Avalos, MD, +56974785169, pabloavalosc@gmail.com

    Mauricio A Cuello, MD, +56223543034, mcuello@uc.cl

  • Hospital regional de Coyhaique

    Coyhaique, Aysén, 5951801

    Pablo Mardones, MD, +56998881617, jefeobstetriciahrc@saludaysen.cl

    Mauricio A Cuello, MD, +56223543034, mcuello@uc.cl

  • San Jorge Medical Center UC-Christus Health Network

    Santiago, Metropolitan Region, 7580153

    Nicolas A Saez, MD, +56963940423, nsaez@ucchristus.cl

    Mauricio A Cuello, MD, +56982391249, mcuello@uc.cl

  • San Joaquín Medical Center, UCChristus Health Network

    Santiago, Metropolitan Region, 7820436

    Nicolas Saez, MD, +56963940423, nsaez@ucchristus.cl

    Mauricio A Cuello, MD, +56982391249, mcuello@uc.cl

  • Ancora San Francisco Medical Center UC Christus Health Network

    Santiago, Metropolitan Region, 8150031

    Nicolás Saez, MD, +56963940423, nsaez@ucchristus.cl

    Mauricio A Cuello, MD, +56982391249, mcuello@uc.cl

  • Cancer Centre UC-Christus Nuestra Sra de la Esperanza

    Santiago, Metropolitan Region, 8330032

    Mauricio A Cuello, MD, +56982391249, mcuello@uc.cl

    Nicolas Saez, MD, +56963940423, nsaez@ucchristus.cl

  • Santa Lucia Medical Center UC-Christus Health Network

    Santiago, Metropolitan Region, 8331010

    Nicolas Saez, MD, +56963940423, nsaez@ucchristus.cl

    Mauricio A Cuello, MD, +56982391249, mcuello@uc.cl

  • Hospital de Talca

    Talca, Maule Region, 3460001

    Yesica Sagredo, MD, +56983354093, sagredo.yesica@gmail.com

    Mauricio A Cuello, MD, +56223543034, mcuello@uc.cl

Other trials in Chile

About this study

Official title: 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.

Read more

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.

Read the 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.

Keywords
HPV self-sampling, Digital colposcopy, Telemedicine, Diagnostic prioritization, Cervical cancer screening
Medical subject headings
Uterine Cervical Neoplasms, Uterine Cervical Dysplasia, Papillomavirus Infections

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Up to 6 months

Secondary outcomes (5)

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

    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.

    Measured: Baseline

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

    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.

    Measured: Baseline

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

    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.

    Measured: Up to 6 months

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

    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.

    Measured: Up to 6 months

  5. Time to diagnostic resolution

    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.

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2026
  2. Study start30 Jun 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07593066
Sponsor's protocol ID
UC-CCU-PRIORITY-2026
Other IDs
FNC-2025-1440
Acronym
PRIORITY
Status last verified
Apr 2026
First submitted
29 Apr 2026
Last updated
18 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Cancer and Cervical Intraepithelial Neoplasia, run by Pontificia Universidad Catolica de Chile at 8 sites in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mauricio A Cuello, MD (+56223543034, mcuello@uc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic accuracy of the integrated molecular and digital model for detection of CIN2+ (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07593066.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.

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PRIORITY Study in Cervical Cancer (NCT07593066) | AzTrials