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临床试验/NCT02838381
NCT02838381已完成不适用

Study of Genetic and Cellular Immunological Parameters Predictive of Disease-free Survival in Patients With Metastatic Cancer

Centre Hospitalier Universitaire de Besancon2 个研究点 分布在 1 个国家目标入组 553 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
553
试验地点
2
主要终点
frequency of peripheral T cell immune responses in the presence of antigenic peptides associated with digestive cancer

研究概览

简要总结

The aim of this study is to characterize the genetic and cellular immunological parameters of metastatic digestive cancer patients having short and long responses to chemotherapy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • For all patients:
  • signed written informed consent
  • For cohort A:
  • patient with metastatic colorectal cancer with first-line therapy by chemotherapy +/- surgery and with a disease-free survival > or = at 20 months
  • Ct-scan realized in the previous 4 weeks and showing no progression according to the Recist criteria v1.1
  • For cohort B:
  • patient treated for metastatic colorectal cancer and chemotherapy responder (obtention of an objective response according to the Recist criteria V1.1 in first-line therapy), with a disease-free survival < 10 months (disease progression must be confirmed by CT scan evaluation according to Recist v1.1 criteria)
  • For cohort C:
  • patients with no metastatic rectum cancer in complete remission after chemotherapy and/or radiotherapy
  • For cohort D:
  • patients with metastatic or locally advanced cancer in complete remission after treatment, non eligible in the other cohorts

排除标准

  • For all patients:
  • patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study
  • patient with a neurodegenerative disease
  • patient under guardianship, curator or under the protection of justice

结局指标

主要结局

frequency of peripheral T cell immune responses in the presence of antigenic peptides associated with digestive cancer

时间窗: at inclusion

progression-free survival

时间窗: within 5 years after the inclusion

time interval between the date of inclusion and the date of first progression or death from any cause.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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