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临床试验/NCT02960282
NCT02960282终止不适用

The Role of Microbiome in Cancer Therapy

University of Southern California1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2016年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
21
试验地点
1
主要终点
Best tumor response, defined as a complete response or a clear decrease in tumor burden

研究概览

简要总结

This research trial studies the gut microbiome in fecal samples from patients with cancer that has spread to other parts of the body who are undergoing chemotherapy or immunotherapy. Studying samples of feces from patients with metastatic cancer in the laboratory may help doctors learn if the make-up of the gut microbiome has a positive or negative influence to a patient's response to chemotherapy or immunotherapy.

详细描述

PRIMARY OBJECTIVES:

I. To quantitatively determine the composition of the microflora and their gene and protein expression levels in patients with metastatic colorectal cancer being treated with fluorouracil (5-FU) based chemotherapy, or anti-PD1 immunotherapy.

SECONDARY OBJECTIVES:

I. Compare the changes in species composition and in the metabolic activities (as determined in the primary objective) with response to chemotherapy or immunotherapy.

II. Compare the changes in species composition and in the metabolic activities (as determined in the primary objective) with toxicities and side effects resulting with chemotherapy or immunotherapy.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Must be willing and able to provide fecal samples according to protocol schedule
  • Diagnosis of metastatic colorectal cancer, where the metastatic disease has not been previously treated
  • Scheduled to begin fluorouracil/leucovorin calcium/oxaliplatin (FOLFOX) or folinic acid-fluorouracil-irinotecan (FOLFIRI) based chemotherapy for the advanced disease
  • Must have radiologic evidence of disease
  • Diagnosis of metastatic cancer
  • Scheduled to begin pembrolizumab or another anti-PD-1 or anti-PD-L1 antibody as single agent therapy for the treatment of the advanced disease
  • Must have physical or radiologic evidence of disease

排除标准

  • Patients with a colostomy or any other issues that may prevent the standard methods for collection of stool are not eligible for this study
  • Patients are not enrolled or a research protocol for treatment

结局指标

主要结局

Best tumor response, defined as a complete response or a clear decrease in tumor burden

时间窗: Up to 2 years

The presence and amounts of species and their protocols will be compared to tumor response.

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 (1)

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