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Идёт набор NCT06139042

Early-stage Detection of LIver, Biliary TRAct and PancReatic Cancers

— Наблюдательное Liver Cancer Biliary Tract Cancer 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
В протоколе указаны: Blood drawing.
Кому может быть актуально
Состояния в реестре: Liver Cancer, Biliary Tract Cancer, 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

Early-stage Detection of LIver, Biliary TRAct and PancReatic Cancers by Liquid BiopsY in Periphheral Blood: a Prospective Study (LIBRARY Study)

Обзор

LIBRARY is a prospective, multi-center, observational study aimed at detecting early liver, biliary tract, and pancreatic cancers by combining assays of cell-free DNA (cfDNA) methylation, serum protein, and microRNA.

Подробное описание

LIBRARY is a prospective, multi-center, observational study aimed at detecting early liver, biliary tract, and pancreatic cancers by combining assays of cell-free DNA (cfDNA) methylation, serum protein, and microRNA. The study will enroll approximately 458 participants diagnosed with liver, biliary tract, and pancreatic cancers, 330 individuals with corresponding benign diseases and 820 healthy participants.

Вмешательства

  • Диагностический тест Blood drawing
    The participants had their blood drawn.

Первичные конечные точки

  • The sensitivity and specificity of the cfDNA methylation model in detection of liver, biliary tract and pancreatic cancers. [Срок оценки: 24 months]
Вторичные конечные точки (2)
  • The sensitivity and specificity of the combined model in detection of different subtypes of cancers. [Срок оценки: 24 months]
  • The sensitivity and specificity of the combined model in detection of different stages of liver, biliary tract and pancreatic cancers. [Срок оценки: 24 months]

Критерии участия

Criteria:

Inclusion Criteria for Cancer Arm Participants:

Age 40-75 years at the day of consenting to the study. Able to provide a written informed consent. Pathologically confirmed liver, biliary tract and pancreatic cancers. No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw.

Exclusion Criteria for Cancer Arm Participants:

Pregnancy or lactating women. Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant.

Recipients of blood transfusion within 7 days prior to study blood draw. Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancers.

With other known malignant tumors or multiple primary tumors.

Inclusion Criteria for Benign Arm Participants:

Age 40-75 years at the day of consenting to the study. Able to provide a written informed consent. Confirmed diagnosis of benign liver, biliary tract and pancreatic diseases. No prior radical treatment of the benign diseases prior to study blood draw.

Exclusion Criteria for Benign Arm Participants:

Pregnancy or lactating women. Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant.

Recipients of blood transfusion within 7 days prior to study blood draw. Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancers.

Confirmed diagnosis of malignancies or precancerous lesion. A history of malignant tumors.

Inclusion Criteria for Healthy Arm Participants:

  • Able to provide a written informed consent.
  • Able to provide sufficient and qualified blood samples for study tests.
  • No cancer related symptoms within 30 days prior to study screening.
  • Cancer history with curative treatment completed over 3 years without recurrence prior to study enrollment.

Exclusion Criteria for Healthy Arm Participants:

  • Insufficient qualified blood sample for study test.
  • During pregnancy or lactation.
  • Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
  • Recipient of blood transfusion within 30 days prior to study blood draw.
  • Recipient of anti-infectious therapy within 14 days prior to study blood draw.
  • Have received or are undergoing curative cancer treatment within three years prior to study screening.
  • With autoimmune or other diseases with severe comorbidities.

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 · 1 центр
  • The Second Affiliated Hospital, Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT06139042 · 2023-0871

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗