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Набор скоро начнётся NCT07390643

The DISCOVER Study

Без фазы С лечением Cancer Cancer Diagnosis

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: GRAIL Galleri MCED test.
Кому может быть актуально
Состояния в реестре: Cancer, Cancer Diagnosis. Базовые параметры: от 22 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
США
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

Determining ImpactS of Multi-Cancer Early detectiOn Tests oVER Time in Symptomatic Patients: The DISCOVER Study

Обзор

The purpose of this research study is to evaluate the possible benefits of screening with an investigational, but commercially available blood test designed to detect many types of cancer. The name of the screening blood test being studied is: -GRAIL Galleri MCED test

Подробное описание

The purpose of this pilot research study is to evaluate the possible benefits of screening with an investigational, but commercially available blood test designed to detect many types of cancer. "Investigational" means that this test is being studied and is not approved or cleared by the Food and Drug Administration (FDA).

The multi-cancer early detection test looks for small pieces of genetic material, called DNA (deoxyribonucleic acid), in the blood that may indicate the presence of cancer, and the test may also be able to suggest what type of cancer is present.

The research study procedures include screening for eligibility, in-clinic visit, blood tests, and questionnaires.

It is expected that about 110 people will take part in this research study.

Вмешательства

  • Устройство GRAIL Galleri MCED test
    A multi-cancer early detection (MCED) blood test.

Первичные конечные точки

  • Multi-cancer Early Detection (MCED) Positive Cancer Type [Срок оценки: MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.]
  • Multi-cancer Early Detection (MCED) Positive Cancer Incidence [Срок оценки: MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.]
  • Multi-cancer Early Detection (MCED) Positive Cancer Stage [Срок оценки: MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.]
  • Multi-cancer Early Detection (MCED) Undetected Cancer Type [Срок оценки: MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.]
  • Multi-cancer Early Detection (MCED) Undetected Cancer Incidence [Срок оценки: MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.]
  • Multi-cancer Early Detection (MCED) Undetected Cancer Stage [Срок оценки: MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.]
Вторичные конечные точки (5)
  • Positive Predictive Value (PPV) of Multi-cancer Early Detection (MCED) [Срок оценки: 12 months]
  • Number of Additional Tests [Срок оценки: MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.]
  • Types of Additional Tests [Срок оценки: MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.]
  • Tissue of Origin Correct Prediction Rate [Срок оценки: MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.]
  • Qualitative Provider Assessment of MCED Test Utility [Срок оценки: 24 months]

Критерии участия

Критерии включения

  • Be at least 22 years old
  • Have signs and symptoms suggestive of cancer and/or have imaging related to signs and symptoms of cancer being evaluated in the Cancer Diagnostic Service clinic

Критерии исключения

  • Individuals diagnosed with invasive malignancy within 3 years of enrollment
  • Individuals with active cancer requiring active therapeutic intervention at the time of participation (hormone therapy for breast/prostate cancer is considered acceptable and will not preclude participation)

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

США · 1 центр
  • Dana-Farber Cancer Institute — Boston

Идентификаторы

NCT: NCT07390643 · 25-467

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗