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Идёт набор NCT05227534

Multi-canceR Early-detection Test in Asymptomatic Individuals (PREVENT)

Без фазы С лечением Cancer Early Detection of Cancer Circulating Cell-free DNA

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: OverC multi-cancer detection blood test.
Кому может быть актуально
Состояния в реестре: Cancer, Early Detection of Cancer, Circulating Cell-free DNA. Базовые параметры: 40 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Prospective Multi-canceR Early-detection and interVENTional Study in Asymptomatic Individuals: PREVENT

Обзор

PREVENT is a prospective, multicenter, interventional study evaluating the performance of the OverC multi-cancer detection blood test in asymptomatic individuals with cancer risk.

Подробное описание

Participants will receive the OverC multi-cancer detection blood test along with standard-of-care screening, whose results will be returned to health care providers and participants. The diagnostic procedures will be guided firstly by the OverC multi-cancer detection blood test and then by the standard-of-care screening. The number, cancer types, and cancer clinical stage of cancer patients diagnosed via the OverC multi-cancer detection blood test will be recorded.

The study will enroll approximately 12,500 participants as defined by eligibility criteria with an anticipated enrollment period of approximately 9 months at up to 30 clinical sites within China. Participants will be actively followed for approximately 5 years from the date of their enrollment.

Вмешательства

  • Устройство OverC multi-cancer detection blood test
    Blood collection for the OverC multi-cancer detection blood test and standard-of-care screening with return of results

Первичные конечные точки

  • The cancer clinical stages of cancer patients diagnosed via the multi-cancer detection blood test [Срок оценки: Up to 5 years]
  • Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for the multi-cancer detection test alone or with standard-of-care screening as evaluated after 1-year follow-up [Срок оценки: Up to 1 year]
Вторичные конечные точки (4)
  • Changes in health-related quality of life in individuals with a positive result of the multi-cancer detection test assessed by Short Form Health Survey (SF-12v2) [Срок оценки: Up to 5 years]
  • Changes in anxiety as evaluated by Self-rating Anxiety Scale (SAS) of individuals with a positive result of the multi-cancer detection test [Срок оценки: Up to 5 years]
  • Satisfaction with the multi-cancer detection test [Срок оценки: Up to 5 years]
  • Sensitivity, specificity, PPV, and NPV for the multi-cancer detection blood test alone or with standard-of-care screening as evaluated after 3- and 5-year follow-up [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

  • Participants must be able to provide a written informed consent form
  • Participants must not have received any colonoscopy, abdominal MRI/CT, low-dose CT, or chest CT within 5 years before signing the informed consent form
  • Participants must be able to provide blood samples for study tests
  • Participants must be between 40 and 75 years old

Критерии исключения

  • Individuals who have an acute infection or inflammation within 14 days prior to recruitment
  • Individuals with cancer-associated clinical symptoms or suspected of cancer
  • Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant
  • Recipient of blood transfusion within 7 days prior to recruitment
  • Individuals who have pure ground-glass opacity
  • Unable to provide blood samples for the multi-cancer early detection blood test
  • Individuals who are unable to tolerate standard-of-care cancer screening tests or have contraindications of standard-of-care cancer screening tests
  • Individuals who have taken medication with anti-tumor effects within 30 days prior to recruitment
  • Individuals who have received or are undergoing curative cancer treatment within three years prior to recruitment
  • Individuals with hemorrhagic diseases
  • Individuals with autoimmune diseases
  • Individuals who are pregnant or lactating
  • Individuals who have severe comorbidities that are not suitable for participating in the trial judged by researchers

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Скрининг

Центры проведения

Китай · 1 центр
  • West China Hospital, Sichuan University — Чэнду

Идентификаторы

NCT: NCT05227534 · RSCD2022006

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗