NCT04600180进行中（未招募）不适用
Deep Phenotyping of the Gut Immune System During Immune Checkpoint Inhibitor Therapy - DEFENCE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- CD8+ T cell count in the gut mucosa
研究概览
简要总结
This exploratory study aims to gain insight in gut immune system phenotypes before and after immunotherapy. After informed consent is obtained, sigmoidoscopies at baseline and during treatment with immunotherapy will be performed, During the endoscopies, biopsies from the sigmoid and rectum will be obtained. Subsequent immune cell analyses in these biopsies will be performed. Parallel to the sigmoidoscopies, venous blood samples will be obtained to monitor inflammatory markers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Indication for treatment with anti PD1/PDL1 based immunotherapy
- •Written informed consent
- •Evaluable according to iRECIST v1.1
排除标准
- •Concomitant, chronic or infectious illness in the past 6 months causing moderate to severe colitis
- •Use of a medication in the past 6 months with an elevated risk of moderate to severe colitis
- •Gastrointestinal resection or enterostomy
- •Abdominal radiotherapy in the past 6 months
结局指标
主要结局
CD8+ T cell count in the gut mucosa
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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