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Идёт набор NCT06217900

a PROspective Case Control Study to Develop and Validate a Blood Test FOr mUlti-caNcers Early Detection（PROFOUND）

— Наблюдательное 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: 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
Китай
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

PROFOUND Study: Development and Validation of a Multi-cancer Early Detection Model Based on Peripheral Blood Multi-omic Analysis and Machine Learning: a Multicenter, Prospective, Observational, Case-control Study

Обзор

This study is a multi-center, case-control study aiming at developing and blinded testing machine learning-based multiple cancers early detection model by prospectively collecting blood samples from newly diagnosed cancer patients and individuals without confirmed cancer diagnosis.

Подробное описание

Blood samples from newly diagnosed cancer patients and individuals without confirmed cancer diagnosis will be prospectively collected to identify cancer-specific circulating signals through integrative multi-omic analysis. Based on the comprehensive molecular profiling, a machine learning-driven model will be trained and blinded validated independent through a two-stage approach in clinically annotated individuals. Approximately 10327 cancer patients will be enrolled in this study and early-stage cancer patients will be enriched to improve the model sensitivity on distinguishing cancers with favorable prognosis. Approximately 6339 age and sex matched controls will be included in model development, which are volunteers without a cancer diagnosis after routine cancer screening tests.

Первичные конечные точки

  • The performance of cfDNA methylation-based multiple cancers early detection model in case-control study [Срок оценки: 12 months]
Вторичные конечные точки (3)
  • The performance of cfDNA methylation-based multiple cancers early detection model in early stage cancer cases [Срок оценки: 12 months]
  • The performance of multi-omic-based multiple cancers early detection model in case-control study [Срок оценки: 12 months]
  • The performance of different multi-cancer early detection models in different subgroups [Срок оценки: 12 months]

Критерии участия

Inclusion Criteria for Case Arm Participants:

  • 40-74 years old
  • Clinically and/or pathologically diagnosed cancer
  • No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc.
  • Able to provide a written informed consent and willing to comply with all part of the protocol procedures

Exclusion Criteria for Case Arm Participants:

  • Pregnancy or lactating women
  • Known prior or current diagnosis of other types of malignancies comorbidities
  • Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) or febrile illness (body temperature of ≥ 38.5 °C) within 14 days prior to screen
  • Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
  • Recipients of blood transfusion within 30 days prior to screen
  • Recipients of therapy in past 14 days prior to screen, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide
  • Unsuitable for this trial determined by the researchers

Inclusion Criteria for Control Arm Participants:

  • 40-74 years old
  • Without confirmed cancer diagnosis
  • Able to provide a written informed consent and willing to comply with all part of the protocol procedures

Exclusion Criteria for Control Arm Participants:

  • Pregnancy or lactating women
  • Known prior or current diagnosis of other types of malignancies comorbidities
  • Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) or febrile illness (body temperature of ≥ 38.5 °C) within 14 days prior to screen
  • Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
  • Recipients of blood transfusion within 30 days prior to screen
  • Recipients of therapy in the past 14 days prior to screen, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide
  • Unsuitable for this trial determined by the researchers

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Китай · 2 центра
  • Peking University People's Hospital — Пекин
  • Peking University Cancer Hospital and Institute — Пекин

Идентификаторы

NCT: NCT06217900 · PROFOUND

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗