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临床试验/NCT03316456
NCT03316456已完成不适用

The Role of Gut Microbiota in Intestinal Barrier Damage in Acute Leukemia Patients Undergoing Inpatient Induction Chemotherapy

Masonic Cancer Center, University of Minnesota1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年8月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Variation of Gut Microbiota Composition and Diversity

研究概览

简要总结

This is an observational study to collect stool, blood, and urine from acute leukemia patients undergoing induction chemotherapy in order to generate preliminary data regarding the association between microbiota and chemotherapy-induced gut barrier damage. This study consists of inpatient collections of blood, urine, and stool while the patients are undergoing inpatient induction therapy. Patients will not be scheduled for any additional procedures or testing beyond what is required for clinical care.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (ages 18 - 99 years) undergoing inpatient induction chemotherapy for newly diagnosed or relapsed acute leukemia (myeloid or lymphoblastic).
  • Any induction regimen (standard or experimental) with planned ~4 weeks of inpatient stay
  • Able to provide written voluntary consent before performance of any study related procedure.

排除标准

  • 未提供

结局指标

主要结局

Variation of Gut Microbiota Composition and Diversity

时间窗: Three times weekly until day 28 of chemotherapy.

Variation of gut microbiota composition and diversity, as determined by 16s rRNA sequencing of serial stool samples, during induction chemotherapy in acute leukemia patients.

次要结局

  • Variation of Gut Barrier Integrity(Three times weekly until day 28 of chemotherapy)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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