Study of Genetic and Cellular Immunological Parameters Predictive of Disease-free Survival in Patients With Metastatic Cancer
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
- 否
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
研究组 & 干预措施
Additional biological samples
Additional blood samples will be realized at the inclusion of patients. Two optional blood samples could be realized if necessary with at least 3 months apart.
Peripheral Blood Mononuclear Cells (PBMC) will be collected. Tissue tumor will be collected if available.
干预措施: Additional biological samples (Other)
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