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临床试验/NCT02599909
NCT02599909撤回不适用

Gut Microbiota in Patients With HCC

National Cancer Institute (NCI)0 个研究点开始时间: 2015年11月6日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
To collect blood/urine/tumor samples, stool, and rectal swabs from HCC patients undergoing resection of primary liver tumors at the Mount Sinai Medical Center and to perform an analysis of the interaction of tumors, immune responses and the gut ...

研究概览

简要总结

Background:

There are about 100 trillion microbial cells in a person s gut. This is called the human gut microbiota. When this is disrupted, it can lead to many diseases. Studies show that the gut microbiota in people with cancer is different than that found in healthy people. Researchers want to study links between the gut microbiota and the immune system in people with a liver disease called hepatocellular carcinoma (HCC).

Objective:

To study links between gut microbiota and the immune system in people with HCC.

Eligibility:

People at least 18 years old with HCC. They must be scheduled to have tumors removed by surgery.

Design:

  • People having surgery for primary liver tumors at the Mount Sinai Medical Center will be screened for this study.
  • At the initial visit, blood, rectal swabs, urine, and stool will be collected. Participants will answer questions about their medical condition.
  • Before surgery, blood, rectal swabs, urine, and stool will be collected. This will be done at a routine visit.
  • When they have surgery, a piece of liver tissue with the tumor will be collected. This will be sent to the National Cancer Institute for tests.
  • After surgery, blood, rectal swabs, urine, and stool will be collected 3 times. This will be done at routine visits.

详细描述

Background:

The human gut microbiota consists of approximately 100 trillion microbial cells whose disruption leads to many diseases including inflammatory bowel disease and colorectal cancer to name a few. Recent studies have shown that cancer patients have an altered gut microbiota when compared to healthy controls. Intestinal microbiota has been proposed to contribute to the start and progression of a number of liver diseases, such as alcoholic liver disease (ALD), nonalcoholic steatohepatitis (NASH), liver cirrhosis, hepatic encephalopathy (HE), and hepatocellular carcinoma (HCC). We plan to investigate the relationship between the gut microbiota and the immune system in patients with HCC. In recent years, immune regulation at the level of the tumor microenvironment has become very important in different types of cancer.

Objectives:

To collect blood/stool/urine/tumor samples and rectal swabs from HCC patients undergoing resection of primary liver tumors at the Mount Sinai Medical Center and to perform an analysis of the interaction of tumors, immune responses and the gut microbiome.

Eligibility:

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

To collect blood/urine/tumor samples, stool, and rectal swabs from HCC patients undergoing resection of primary liver tumors at the Mount Sinai Medical Center and to perform an analysis of the interaction of tumors, immune responses and the gut ...

时间窗: 1 year

Analysis of the interaction of tumors, immune responses and the gut microbiome

次要结局

  • Novel mechanisms how tumors may affect immune responses and gut microbiota(1 year)
  • Correlation between microbiome and patients' clinical outcome(1 year)

研究者

申办方类型
Nih
责任方
Sponsor

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