PRIORITY Study in Cervical Cancer
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Cervical Cancer, Cervical Intraepithelial Neoplasia, HPV Infection. Базовые параметры: 30 лет — 65 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Чили
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The PRIORITY Study in Cervical Cancer: A Prospective Multicenter Observational Evaluation of an Integrated Molecular and Digital Model for Diagnostic Prioritization
Обзор
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.
Подробное описание
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.
Первичные конечные точки
- Diagnostic accuracy of the integrated molecular and digital model for detection of CIN2+ [Срок оценки: Up to 6 months]
Вторичные конечные точки (5)
- Concordance between self-collected and clinician-collected samples for high-risk HPV and extended molecular panel detection [Срок оценки: Baseline]
- Prevalence of sexually transmitted infections and vaginal dysbiosis markers detected by extended molecular screening [Срок оценки: Baseline]
- Prevalence ratio of high-risk HPV positivity in participants with sexually transmitted infections detected by extended molecular screening [Срок оценки: Up to 6 months]
- Odds ratio for histologically confirmed CIN2+ in participants with sexually transmitted infections detected by extended molecular screening [Срок оценки: Up to 6 months]
- Time to diagnostic resolution [Срок оценки: Up to 6 months]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Чили · 8 центров
- Hospital regional de Coyhaique — Coyhaique
- Hospital San Pablo — Coquimbo
- Hospital de Talca — Talca
- San Jorge Medical Center UC-Christus Health Network — Santiago
- San Joaquín Medical Center, UCChristus Health Network — Santiago
- Ancora San Francisco Medical Center UC Christus Health Network — Santiago
- Cancer Centre UC-Christus Nuestra Sra de la Esperanza — Santiago
- Santa Lucia Medical Center UC-Christus Health Network — Santiago
Идентификаторы
NCT: NCT07593066 · UC-CCU-PRIORITY-2026 · FNC-2025-1440