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.
Visão geral do estudo
Status
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Mauricio A Cuello, MD
- Número de telefone: +56223543034
- E-mail: mcuello@uc.cl
Estude backup de contato
- Nome: Nicolás Saez, MD
- Número de telefone: +56223543034
- E-mail: nsaez@ucchristus.cl
Locais de estudo
-
-
Aysén
-
Coyhaique, Aysén, Chile, 5951801
- Hospital regional de Coyhaique
-
Contato:
- Mauricio A Cuello, MD
- Número de telefone: +56223543034
- E-mail: mcuello@uc.cl
-
Contato:
- Pablo Mardones, MD
- Número de telefone: +56998881617
- E-mail: jefeobstetriciahrc@saludaysen.cl
-
Investigador principal:
- Pablo Mardones, MD
-
-
Coquimbo Region
-
Coquimbo, Coquimbo Region, Chile, 1781881
- Hospital San Pablo
-
Contato:
- Mauricio A Cuello, MD
- Número de telefone: +56223543034
- E-mail: mcuello@uc.cl
-
Contato:
- Pablo Avalos, MD
- Número de telefone: +56974785169
- E-mail: pabloavalosc@gmail.com
-
Investigador principal:
- Pablo Avalos, MD
-
-
Maule Region
-
Talca, Maule Region, Chile, 3460001
- Hospital de Talca
-
Contato:
- Mauricio A Cuello, MD
- Número de telefone: +56223543034
- E-mail: mcuello@uc.cl
-
Contato:
- Yesica Sagredo, MD
- Número de telefone: +56983354093
- E-mail: sagredo.yesica@gmail.com
-
Investigador principal:
- Yesica Sagredo, MD
-
-
Metropolitan Region
-
Santiago, Metropolitan Region, Chile, 7580153
- San Jorge Medical Center UC-Christus Health Network
-
Contato:
- Nicolas A Saez, MD
- Número de telefone: +56963940423
- E-mail: nsaez@ucchristus.cl
-
Contato:
- Mauricio A Cuello, MD
- Número de telefone: +56982391249
- E-mail: mcuello@uc.cl
-
Investigador principal:
- Nicolas Saez, MD
-
Subinvestigador:
- Mauricio A Cuello, MD
-
Santiago, Metropolitan Region, Chile, 7820436
- San Joaquín Medical Center, UCChristus Health Network
-
Contato:
- Mauricio A Cuello, MD
- Número de telefone: +56982391249
- E-mail: mcuello@uc.cl
-
Investigador principal:
- Nicolas Saez, MD
-
Contato:
- Nicolas Saez, MD
- Número de telefone: +56963940423
- E-mail: nsaez@ucchristus.cl
-
Santiago, Metropolitan Region, Chile, 8150031
- Ancora San Francisco Medical Center UC Christus Health Network
-
Contato:
- Mauricio A Cuello, MD
- Número de telefone: +56982391249
- E-mail: mcuello@uc.cl
-
Investigador principal:
- Nicolas Saez, MD
-
Contato:
- Nicolas Saez, MD
- Número de telefone: +56963940423
- E-mail: nsaez@ucchristus.cl
-
Santiago, Metropolitan Region, Chile, 8330032
- Cancer Centre UC-Christus Nuestra Sra de la Esperanza
-
Contato:
- Mauricio A Cuello, MD
- Número de telefone: +56982391249
- E-mail: mcuello@uc.cl
-
Contato:
- Nicolas Saez, MD
- Número de telefone: +56963940423
- E-mail: nsaez@ucchristus.cl
-
Investigador principal:
- Mauricio A Cuello, MD
-
Subinvestigador:
- Nicolas Saez, MD
-
Santiago, Metropolitan Region, Chile, 8331010
- Santa Lucia Medical Center UC-Christus Health Network
-
Contato:
- Mauricio A Cuello, MD
- Número de telefone: +56982391249
- E-mail: mcuello@uc.cl
-
Investigador principal:
- Nicolas Saez, MD
-
Subinvestigador:
- Mauricio A Cuello, MD
-
Contato:
- Nicolas Saez, MD
- Número de telefone: +56963940423
- E-mail: nsaez@ucchristus.cl
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Diagnostic accuracy of the integrated molecular and digital model for detection of CIN2+
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Concordance between self-collected and clinician-collected samples for high-risk HPV and extended molecular panel detection
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Participant-Reported Acceptability Score Using the Self-Sampling and Telemedicine Diagnostic Pathway Acceptability Questionnaire
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mauricio A Cuello, MD, Pontificia Universidad Católica de Chile
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças Genitais
- Processos Patológicos
- Neoplasias urogenitais
- Neoplasias por local
- Neoplasias
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Atributos da doença
- Infecções
- Doenças Virais
- Doenças uterinas
- Doenças Genitais Femininas
- Doenças Transmissíveis
- Doenças Sexualmente Transmissíveis, Virais
- Doenças Sexualmente Transmissíveis
- Infecções por vírus de DNA
- Neoplasias Genitais Femininas
- Condições pré-cancerosas
- Doenças do colo do útero
- Neoplasias uterinas
- Infecções por Vírus Tumorais
- Condições Patológicas, Sinais e Sintomas
- Neoplasias do colo uterino
- Infecções por Papilomavírus
- Displasia Cervical Uterina
Outros números de identificação do estudo
- UC-CCU-PRIORITY-2026
- FNC-2025-1440 (Número de outro subsídio/financiamento: Ministry of Health of Chile (National Cancer Fund))
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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.
Prazo de Compartilhamento de 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.
Critérios de acesso de compartilhamento 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.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .