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PRIORITY Study in Cervical Cancer (PRIORITY)

11 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

700

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Mauricio A Cuello, MD
  • Telefoonnummer: +56223543034
  • E-mail: mcuello@uc.cl

Studie Contact Back-up

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Diagnostic accuracy of the integrated molecular and digital model for detection of CIN2+
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Concordance between self-collected and clinician-collected samples for high-risk HPV and extended molecular panel detection
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Participant-Reported Acceptability Score Using the Self-Sampling and Telemedicine Diagnostic Pathway Acceptability Questionnaire
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Pontificia Universidad Catolica de Chile

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

30 juni 2026

Primaire voltooiing (Geschat)

31 december 2026

Studie voltooiing (Geschat)

31 december 2026

Studieregistratiedata

Eerst ingediend

29 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

11 mei 2026

Eerst geplaatst (Werkelijk)

18 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

11 mei 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • UC-CCU-PRIORITY-2026
  • FNC-2025-1440 (Ander subsidie-/financieringsnummer: Ministry of Health of Chile (National Cancer Fund))

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

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-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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