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临床试验/NCT03370861
NCT03370861Unknown不适用

Immunotherapy Multi-omics Specimen Protocol A

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2017年11月8日最近更新:
适应症
相关药物

试验速览

阶段
不适用
入组人数
125
试验地点
1
主要终点
Immune-related Adverse Events (irAEs)

研究概览

简要总结

The purpose of this research study is to examine the relationship between the microbiota (microscopic organisms) in the gut and the activity of the immune system during skin cancer immunotherapy.

详细描述

Details will be available upon publication.

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

入选标准

  • ≥18 years of age.
  • Diagnosis of skin cancer.
  • Planning to initiate or already on ANY type of immunotherapy.
  • Able to provide urine and stool specimens.

排除标准

  • Bowel resection.
  • Major GI surgery in the past 5 years other than cholecystectomy and appendectomy.

结局指标

主要结局

Immune-related Adverse Events (irAEs)

时间窗: 2 years

Electronic medical records will be queried for specific drug-related adverse events known as immune-related Adverse Events (irAEs) including but not limited to colitis, hypophysitis, hepatitis, pneumonitis, pancreatitis, arthritis, rash, and vitiligo.

次要结局

  • Overall Survival(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

William H. McCoy IV, MD, PhD

Research Instructor of Medicine

Washington University School of Medicine

研究点 (1)

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