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Идёт набор NCT06166147

A Prospective Study of Liquid Biopsy for Pancreatic Cancer Early Detection

— Наблюдательное Pancreatic 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: Pancreatic Cancer. 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 →

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Официальное название

A Proof of Concept Study of Pancreatic Cancer Early Detection by cfDNA Assay

Обзор

This study is a multi-center, observational study aiming at developing a machine learning-based early detection model using prospectively collected liquid biopsy samples from clinically-annotated individuals.

Подробное описание

Peripheral blood samples from participants with new diagnosis of pancreatic cancers will be collected to characterize the cancer-specific circulating signals by sequencing cell free DNA. A noninvasive test integrating machine learning algorithm will be trained and validated through a two-stage approach in recruited well-classified individuals, along with non-cancers without clinical diagnosis of cancer after routine medical screening. The performance of liquid biospy assays discovering cancer from non-cancer will be evaluated in participants with benign disease as well as average risk individuals.

Первичные конечные точки

  • Performance of cfDNA methylation-based model for discriminating pancreatic cancer versus non-cancer [Срок оценки: 12 months]
Вторичные конечные точки (2)
  • Performance of models using multi-omic data for discriminating pancreatic cancer versus non-cancer [Срок оценки: 12 months]
  • Performance of pre-defined model in clinical sub-groups of interest [Срок оценки: 12 months]

Критерии участия

Cancer Arm

Критерии включения

  • 40-75 years old
  • Clinically and/or pathologically diagnosed pancreatic 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.

Критерии исключения

  • 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 ≥ 38.0 °C) within 14 days prior to blood draw
  • Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
  • Recipients of blood transfusion within 30 days prior to study blood draw
  • Recipients of therapy in past 14 days prior to blood draw, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamine, hydrazine, arsenic trioxide
  • Other conditions that the investigators considered are not suitable for the enrollment

Benign Disease Arm

Критерии включения

  • 40-75 years old
  • Clinically and/or pathologically diagnosed pancreatic non-malignant disease (pancreatic intraepithelial neoplasia, pancreatic cyst and chronic pancreatitis)
  • 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

Критерии исключения

  • 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 ≥ 38.0 °C) within 14 days prior to blood draw
  • Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
  • Recipients of blood transfusion within 30 days prior to study blood draw
  • Recipients of therapy in past 14 days prior to blood draw, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamine, hydrazine, arsenic trioxide
  • Other conditions that the investigators considered are not suitable for the enrollment

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Китай · 3 центра
  • Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Cente — Шанхай
  • Department of Hepato-Biliary-Pancreatic-Splenic Surgery, Shanghai General Hospital — Шанхай
  • Department of General Sugery, Huadong Hospital — Шанхай

Идентификаторы

NCT: NCT06166147 · Profound-PC

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗