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Идёт набор NCT04226313

Self-sampling for Non-attenders to Cervical Cancer Screening

Без фазы С лечением Cervical Cancer Cervical Dysplasia Human Papillomavirus Infection

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
В протоколе указаны: Self-sampling by Evalyn Brush, Self sampling by Evalyn Brush home or in GP´s clinic.
Кому может быть актуально
Состояния в реестре: Cervical Cancer, Cervical Dysplasia, Human Papillomavirus 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
Чехия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Cervical Cancer Prevention Using Self-sampling and Human Papillomavirus Detection

Обзор

The trial will evaluate whether self-sampling and human papillomavirus (HPV) testing may increase cervical cancer screening attendance among under-screened women in Czech Republic. Different ways of offering self-sampling device will be evaluated.

Подробное описание

Despite the existence of an effective cervical cancer screening in the Czech Republic, cervical cancer is the cause of about 800 new cases and 400 deaths every year. One of the major problem of the Czech cervical cancer screening is low participation. An effective strategy to increase cervical cancer screening attendance is one of the main challenges. The offering of self-sampling to the cervical cancer screening non-attenders could increase women's participation as was shown in several European countries.

The trial should determine acceptability of the self-sampling followed by HPV DNA test by Czech women and therefore usability of the self-sampling device to increase cervical cancer screening attendance among under-screened women. Three different approaches will be tested: women will receive a self-sampling device by mail (Arm A); receive a self-sampling device by gynecologist (Arm B); receive a self-sampling device by general practitioner (Arm C). Comparisons of the screening attendance among the arms will be made. To address also potential effects on inequities, the analyses will include comparisons by sociodemographic characteristics. Women from the database of commercial vendor will be included to the Arm A regardless of whether or not they participate in cervical cancer screening program. Women who do not participate in cytology-based cervical cancer screening program for at least three years will be included through their gynecologist (Arm B) or general practitioner (Arm C) database.

The second focus of the trial is the evaluation of high-risk human papillomavirus prevalence in screening population of Czech women (attenders and non-attenders of cervical cancer screening) since there are no relevant data for the Czech Republic. Study participants may volunteer for archiving of remaining biological materials for future studies.

Вмешательства

  • Диагностический тест Self-sampling by Evalyn Brush
    Women will perform a cervicovaginal self-sampling at their home using Evalyn Brush.
  • Диагностический тест Self sampling by Evalyn Brush home or in GP´s clinic
    Women will perform a cervicovaginal self-sampling at their home or the GP´s clinic using Evalyn Brush

Первичные конечные точки

  • Screening participation [Срок оценки: 12 months]
  • Prevalence of high-risk HPV [Срок оценки: 12 months]
Вторичные конечные точки (1)
  • Sociodemographic characteristics [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • Women with age 30-65 years; for arm A women > 65 years are allowed
  • Women live in the Czech Republic.
  • Women who have not participate in cervical cancer screening program in the Czech Republic for at least 3 years (Arm B and C).
  • Women with completed informed consent.
  • Women capable of self-sampling of cervicovaginal swab.

Критерии исключения

  • Pregnant women.
  • Women with no sexual intercourse experience.
  • Women after hysterectomy including cervix.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Скрининг

Центры проведения

Чехия · 1 центр
  • University Hospital Olomouc — Olomouc

Идентификаторы

NCT: NCT04226313 · 5850

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗