PRIORITY Study in Cervical Cancer (PRIORITY)
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.
Aperçu de l'étude
Statut
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Mauricio A Cuello, MD
- Numéro de téléphone: +56223543034
- E-mail: mcuello@uc.cl
Sauvegarde des contacts de l'étude
- Nom: Nicolás Saez, MD
- Numéro de téléphone: +56223543034
- E-mail: nsaez@ucchristus.cl
Lieux d'étude
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Aysén
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Coyhaique, Aysén, Chili, 5951801
- Hospital regional de Coyhaique
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Contact:
- Mauricio A Cuello, MD
- Numéro de téléphone: +56223543034
- E-mail: mcuello@uc.cl
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Contact:
- Pablo Mardones, MD
- Numéro de téléphone: +56998881617
- E-mail: jefeobstetriciahrc@saludaysen.cl
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Chercheur principal:
- Pablo Mardones, MD
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Coquimbo Region
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Coquimbo, Coquimbo Region, Chili, 1781881
- Hospital San Pablo
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Contact:
- Mauricio A Cuello, MD
- Numéro de téléphone: +56223543034
- E-mail: mcuello@uc.cl
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Contact:
- Pablo Avalos, MD
- Numéro de téléphone: +56974785169
- E-mail: pabloavalosc@gmail.com
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Chercheur principal:
- Pablo Avalos, MD
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Maule Region
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Talca, Maule Region, Chili, 3460001
- Hospital de Talca
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Contact:
- Mauricio A Cuello, MD
- Numéro de téléphone: +56223543034
- E-mail: mcuello@uc.cl
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Contact:
- Yesica Sagredo, MD
- Numéro de téléphone: +56983354093
- E-mail: sagredo.yesica@gmail.com
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Chercheur principal:
- Yesica Sagredo, MD
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Metropolitan Region
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Santiago, Metropolitan Region, Chili, 7580153
- San Jorge Medical Center UC-Christus Health Network
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Contact:
- Nicolas A Saez, MD
- Numéro de téléphone: +56963940423
- E-mail: nsaez@ucchristus.cl
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Contact:
- Mauricio A Cuello, MD
- Numéro de téléphone: +56982391249
- E-mail: mcuello@uc.cl
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Chercheur principal:
- Nicolas Saez, MD
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Sous-enquêteur:
- Mauricio A Cuello, MD
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Santiago, Metropolitan Region, Chili, 7820436
- San Joaquín Medical Center, UCChristus Health Network
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Contact:
- Mauricio A Cuello, MD
- Numéro de téléphone: +56982391249
- E-mail: mcuello@uc.cl
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Chercheur principal:
- Nicolas Saez, MD
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Contact:
- Nicolas Saez, MD
- Numéro de téléphone: +56963940423
- E-mail: nsaez@ucchristus.cl
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Santiago, Metropolitan Region, Chili, 8150031
- Ancora San Francisco Medical Center UC Christus Health Network
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Contact:
- Mauricio A Cuello, MD
- Numéro de téléphone: +56982391249
- E-mail: mcuello@uc.cl
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Chercheur principal:
- Nicolas Saez, MD
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Contact:
- Nicolas Saez, MD
- Numéro de téléphone: +56963940423
- E-mail: nsaez@ucchristus.cl
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Santiago, Metropolitan Region, Chili, 8330032
- Cancer Centre UC-Christus Nuestra Sra de la Esperanza
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Contact:
- Mauricio A Cuello, MD
- Numéro de téléphone: +56982391249
- E-mail: mcuello@uc.cl
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Contact:
- Nicolas Saez, MD
- Numéro de téléphone: +56963940423
- E-mail: nsaez@ucchristus.cl
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Chercheur principal:
- Mauricio A Cuello, MD
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Sous-enquêteur:
- Nicolas Saez, MD
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Santiago, Metropolitan Region, Chili, 8331010
- Santa Lucia Medical Center UC-Christus Health Network
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Contact:
- Mauricio A Cuello, MD
- Numéro de téléphone: +56982391249
- E-mail: mcuello@uc.cl
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Chercheur principal:
- Nicolas Saez, MD
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Sous-enquêteur:
- Mauricio A Cuello, MD
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Contact:
- Nicolas Saez, MD
- Numéro de téléphone: +56963940423
- E-mail: nsaez@ucchristus.cl
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Diagnostic accuracy of the integrated molecular and digital model for detection of CIN2+
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Concordance between self-collected and clinician-collected samples for high-risk HPV and extended molecular panel detection
Délai: 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
|
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Prevalence of sexually transmitted infections and vaginal dysbiosis markers detected by extended molecular screening
Délai: 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
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Prevalence ratio of high-risk HPV positivity in participants with sexually transmitted infections detected by extended molecular screening
Délai: 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
Délai: 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
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Participant-Reported Acceptability Score Using the Self-Sampling and Telemedicine Diagnostic Pathway Acceptability Questionnaire
Délai: 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
|
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Direct transportation costs associated with the diagnostic pathway
Délai: Up to 6 months
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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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Mauricio A Cuello, MD, Pontificia Universidad Católica de Chile
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies génitales
- Processus pathologiques
- Tumeurs urogénitales
- Tumeurs par site
- Tumeurs
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Attributs de la maladie
- Infections
- Maladies virales
- Maladies utérines
- Maladies génitales, femme
- Maladies transmissibles
- Maladies sexuellement transmissibles, virales
- Maladies sexuellement transmissibles
- Infections par le virus de l'ADN
- Tumeurs génitales, femme
- Conditions précancéreuses
- Maladies du col de l'utérus
- Tumeurs utérines
- Infections virales tumorales
- Conditions pathologiques, signes et symptômes
- Tumeurs du col de l'utérus
- Infections à papillomavirus
- Dysplasie cervicale utérine
Autres numéros d'identification d'étude
- UC-CCU-PRIORITY-2026
- FNC-2025-1440 (Autre subvention/numéro de financement: Ministry of Health of Chile (National Cancer Fund))
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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.
Délai de partage IPD
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.
Critères d'accès au partage IPD
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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
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