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临床试验/NCT04707365
NCT04707365尚未招募不适用

Interactions Between Tumor, Tumor Microenvironment and Immune System in Digestive Cancers : Impact on Survival and Response to Treatment

Assistance Publique - Hôpitaux de Paris0 个研究点目标入组 200 人开始时间: 2021年3月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
主要终点
overall survival

研究概览

简要总结

Colorectal and pancreatobiliary cancers are the most common digestive cancers. Their incidence has particularly increased over the last few decades, leading to suspicion that environmental factors are involved. In addition, strategies for the therapeutic management of these cancers are evolving in the context of the development of immunotherapies.

Tumor microenvironment is a potential source of new diagnostic, prognostic and predictive markers and new therapeutic targets. The links between tumor microenvironment and modulation of the immune system in colorectal and pancreatobiliary cancers are poorly understood. Molecular classifications have been proposed for these cancers, but their link with immunity and response to treatment remains to be explored.

Objective : explore links between molecular subtypes, tumor microenvironment, host (immune system, pre-metastatic niche, intestinal microbiota, metabolism), and survival (prognostic value), response (predictive value) and tolerance (toxicities) to treatments in digestive cancers, in particular colorectal and pancreatobiliary cancers.

Method: Retrospective and prospective monocentric cohort study

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Colorectal or pancreatic adenocarcinoma or biliary tract adenocarcinoma
  • Cytologically or histologically proven adenocarcinoma, regardless of stage and treatment
  • Age ≥ 18 years old
  • Diagnosed from 2015 onwards
  • Signed Consent
  • Affiliation to a social security scheme (including CMU (Universal health coverage))

排除标准

  • Patient under guardianship, curatorship or safeguarding of justice
  • Pregnant or breastfeeding woman
  • Any medical, psychological or social situation that could prevent compliance with the protocol according to the investigator's assessment.
  • Refusal to participate in the study
  • Patient on AME (state medical assistance)
  • Persons deprived of liberty by a judicial or administrative decision
  • Persons under psychiatric care

结局指标

主要结局

overall survival

时间窗: observation from first cancer treatment date until date of death or 10 years follow up if patient alive

Overall survival (OS): vital status (alive/deceased)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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