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Набор скоро начнётся NCT06790355

ProSight: a Multi-centre Interventional Study Evaluating MCED in Asymptomatic Population

Без фазы С лечением Lung Cancer Colorectal Cancer Liver Cancer Grastic 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
В протоколе указаны: multi-cancer early detection.
Кому может быть актуально
Состояния в реестре: Lung Cancer, Colorectal Cancer, Liver Cancer, Grastic Cancer. Базовые параметры: 40 лет — 74 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
Список центров уточняется — проверьте первичный протокол.
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

Feasibility of Blood-based Test for Multi-cancer Early Detection in Asymptomatic Screening Population（ProSight）: a Multi-centre Interventional Study

Обзор

This is a prospective, multi-centre interventional study evaluating the feasibility of blood-based multi-cancer early detection test in asymptomatic screening cohort.

Подробное описание

Approximately 2527 participants will be enrolled and offered the multi-cancer early detection (MCED) test along with standard-of-care (SOC) cancer screenings and usual medical care. The investigational test is designed to detect five cancer types at a curable stage, which are lung cancer, colorectal cancer, liver cancer, gastric cancer and esophageal cancer. The test provides a binary result and predicts the signal origins if a cancer signal is detected. Those with "cancer signal detected" test results as well as those with warning signs of cancer during health check-up will undergo diagnostic procedures. The diagnostic work-up will be at the discretion of qualified oncologists, instead of being dictated by protocol.

Both the safety and performance of MCED in the screening setting will be evaluated. The extent of diagnostic testing, including laboratory and imaging tests and procedures required to achieve diagnostic resolution, will be recorded and assessed. Additionally, patient-reported outcomes relating to the testing experience will also be collected at specified time points using the Electronic Clinical Outcome Assessment (eCOA) app.

Participants will be actively followed for 1 year from the date of the blood draw.

Вмешательства

  • Устройство multi-cancer early detection
    Blood collection for multi-cancer early detection（MCED）, followed by clinical diagnosis based on the results of MCED and standard-of-care screening

Первичные конечные точки

  • Feasibility of MCED in the intended use setting. [Срок оценки: From enrollment to the Follow-up at 1 year]
  • Safety of MCED in the intended use setting. [Срок оценки: From enrollment to the Follow-up at 1 year]
Вторичные конечные точки (5)
  • Performance of MCED in the intended use setting. [Срок оценки: From enrollment to the Follow-up at 1 year]
  • Cancer signal origin accuracy of MCED. [Срок оценки: From enrollment to the Follow-up at 1 year]
  • Clinical utility of MCED alongside SOC screening. [Срок оценки: From enrollment to the Follow-up at 1 year]
  • Participant-reported psychological impact. [Срок оценки: From enrollment to the Follow-up at 1 year]
  • Participant-reported health related quality of life (HRQoL) . [Срок оценки: From enrollment to the Follow-up at 1 year]

Критерии участия

Критерии включения

  • 40-74 years old
  • Able to provide a written informed consent and willing to comply with all parts of the protocol procedures

Критерии исключения

  • With cancer-associated clinical symptoms or suspected of cancer within 30 days prior to screen
  • Have definite contraindications of cancer screening examination and diagnostic procedures
  • Unable to comply with the protocol procedures
  • Personal history of cancer, diagnosed within the 3 years prior to expected enrollment date
  • Have received or are undergoing curative cancer treatment within three years prior to recruitment. Adjuvant endocrinotherapy for cancer is not an exclusion criterion.
  • Recipients of anti-tumor therapy within 30 days prior to screen
  • Pregnancy or lactating women
  • Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
  • Recipients of blood transfusion within 7 days prior to screen
  • With autoimmune diseases
  • Have an acute infection or inflammation or uncontrolled chronic infection within 14 days prior to blood draw
  • Unsuitable for this trial determined by the researchers (eg. hemorrhagic diseases)

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06790355 · Genie-ProSight

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗