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Идёт набор NCT04011982

PATAKESS Protocol : Clinical and Biological Analysis of Exocrine Pancreatic Tumors

Наблюдательное Exocrine 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: Exocrine Pancreatic Cancer. Базовые параметры: от 18 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

PATAKESS is a monocentric non interventional cohort study (prospective (alive patients) and retrospective (dead patients with biological material from surgery and/or biopsies already collected)). PATAKESS consists of clinical and biological analyses of exocrine pancreatic tumors. Data are derived from tumor samples taken for routine health care purposes in patients managed at Centre Léon Bérard (Lyon-France) since January 2010. The main objective is to determine correlation between biological and clinical characterizations of patients suffering from exocrine pancreatic tumor.

Подробное описание

Pancreatic adenocarcinoma cancer is an aggressive cancer which represents 95% of pancreatic cancer. Pancreatic adenocarcinoma cancer is one of the deadliest cancers (5th cause of death per cancer) ; it has a very poor prognosis: 5-year survival (regardless of all stades at diagnosis). Pancreatic adenocarcinoma cancer is characterized by early metastasis. Therefore, development of efficient systemic therapeutics is one of the keys to improving prognosis. Newly developed immune check-point inhibitors seem to have limited efficacy in pancreatic adenocarcinoma except for MSI-H (Microsatellite instability-high) or dMMR (mismatch repair deficient)/MSI-H tumors.

However, recent data suggest that immune surveillance could control metastatic dissemination of pancreatic adenocarcinoma cancer. Several studies showed strong interactions between pancreatic tumor cells and tumor stroma in metastatic dissemination and in resistance to conventional therapeutics. Many data about pancreatic primitive tumors from murine animals models are available ; however few data on tumor stroma and its interactions with tumor cells of metastasis from adenocarcinoma pancreas are available. Few data on correlation between molecular alterations types (mutations, deletions, amplifications) in pancreatic adenocarcinoma cells and tumor stroma characteristics (primitive and metastatic stroma (cells composition, immune infiltration)) are also available.

In PATAKESS study, clinical and biological data are derived from tumor samples taken for routine health care purposes in patients managed at Centre Léon Bérard (Lyon-France) since January 2010.

Первичные конечные точки

  • Determination of the correlation between clinical characterizations and biological characterizations of patients suffering from exocrine pancreatic cancer [Срок оценки: Up to 72 months]
Вторичные конечные точки (4)
  • Comparison of different tumor stroma : from surgery specimen of primitive tumor with preoperative chemotherapy, versus from surgery specimen of primitive tumor without preoperative chemotherapy, versus from biopsies done before chemotherapy [Срок оценки: Up to 72 months]
  • Comparison of different tumor stroma : from surgery specimen of primitive tumor with preoperative chemotherapy, versus from surgery specimen of primitive tumor without preoperative chemotherapy, versus from biopsies done before chemotherapy [Срок оценки: Up to 72 months]
  • Comparison of healthy tissu and tumor stroma from primitive tumor versus from metastases [Срок оценки: Up to 72 months]
  • Comparison of healthy tissu and tumor stroma from primitive tumor versus from metastases [Срок оценки: Up to 72 months]

Критерии участия

Критерии включения

  • Male or female patient 18 age or older
  • Patient operated on for exocrine pancreatic adenocarcinoma at Centre Léon Bérard since 01/01/2010.
  • Histological diagnosis of exocrine pancreatic adenocarcinoma confirmed with surgery specimen.

Критерии исключения

  • Not applicable

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Centre Léon Bérard — Lyon

Идентификаторы

NCT: NCT04011982 · ET19-033 (PATAKESS)

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗