Меню
Идёт набор NCT07030348

Early Diagnosis of Pancreatic Cancer Duodenal Fluid-Based Biomarker Exploratory Study

— Наблюдательное Pancreatic Cancers Pancreatic Diseases

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 Cancers, Pancreatic Diseases. Базовые параметры: от 19 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, South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

Purpose Pancreatic cancer is the fourth leading cancer-related mortality disease in the United States, with a five-year survival rate of 11%, and only 10 15% of all pancreatic cancer patients are operable or borderline operable. Therefore, there is an unmet need for early diagnosis of pancreatic cancer; however, biomarkers related to this are not well understood. This study aims to identify biomarkers for the early diagnosis of pancreatic cancer through duodenal pancreatic juice, which can be easily obtained through an endoscopy.

Подробное описание

Pancreatic cancer is the fourth leading cancer-related mortality disease in the United States, with a five-year survival rate of 11%, which is a very poor prognosis, and only 10-15% of all pancreatic cancer patients are operable or borderline operable.

Therefore, there is an unmet need for early diagnosis of pancreatic cancer; however, the biomarkers of humoral fluids associated with the early diagnosis of pancreatic cancer are not well understood.

Duodenal pancreatic fluids can be easily obtained through an endoscopy and contain a large amount of pancreatic fluid secreted by the pancreas, which is known to be a candidate of biomarkers for early diagnosis of pancreatic cancer.

However, there have been few studies using duodenal fluids in Korea. This study aims to prospectively analyze biomarkers for early diagnosis of pancreatic cancer using duodenal fluids obtained by endoscopy in pancreatic and non-pancreatic cancer groups.

Первичные конечные точки

  • Identification of Biomarkers for Early Pancreatic Cancer Detection [Срок оценки: Up to 1 year from baseline]
Вторичные конечные точки (1)
  • External Validation Using U.S. Samples [Срок оценки: Up to 2 year from baseline]

Критерии участия

Критерии включения

Among the patients requiring gastro-duodenal endoscopy, endoscopic ultrasound, or ERCP for medical purposes, the pancreatic cancer group should meet the criteria numbered 1, 2, and either 3 or 4.

  • Be at least 19 years old.
  • Have completed the informed consent for planned upper endoscopy, endoscopic ultrasound, or endoscopic retrograde cholangiopancreatography before the duodenal fluid collection.
  • A biopsy with proven stage I-IV pancreatic ductal adenocarcinoma (PDAC).
  • Suspected pancreatic cancer on imaging and scheduled for an endoscopic ultrasound-guided pancreatic biopsy.

The non-pancreatic cancer group should meet the criteria numbered 1, 2, and either 3 or 4.

  • Be at least 19 years old.
  • Have completed the informed consent for planned upper endoscopy, endoscopic ultrasound, or endoscopic retrograde cholangiopancreatography before the duodenal fluid collection.
  • Patients with pancreatic cystic tumors or patients with acute or chronic pancreatitis.
  • No evidence of a pancreatic disease.

Критерии исключения

The exclusion criteria for the pancreatic cancer and the non-pancreatic cancer groups will be:

  • Innate or post-surgical anatomy that precludes direct sampling of duodenal fluid.
  • Hemodynamically unstable and unable to have an endoscopy performed.
  • A large amount of ascites fluid that is not controlled and unable to have an endoscopy performed.
  • A coagulation disorder that cannot be corrected and unable to have an endoscopy performed.

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

США · 2 центра
  • University of Colorado Hospital — Aurora
  • Cleveland Clinic — Cleveland
South Korea · 1 центр
  • Asan Medical Center — Seoul

Идентификаторы

NCT: NCT07030348 · DHP_Bio · AMC_IRB_2023-1498

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗