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Gut Microbiota in People With Hepatocellular Carcinoma (HCC)

2018年9月19日 更新者:National Cancer Institute (NCI)

Gut Microbiota in Patients With HCC

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.

研究概览

详细说明

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:

  • Patients 18 years of age and older
  • Patients undergoing liver resection for primary liver cancer
  • Patients must be willing to provide informed consent

Design

  • Blood, stool, rectal swabs, urine and/or tumor samples may be collected from consenting subjects seen at Mount Sinai Medical Center at the initial visit and/or at follow-up visits.
  • Tumor samples will only be obtained from patients undergoing surgery.
  • Patients will be asked to answer a questionnaire.

研究类型

观察性的

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 99年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

  • INCLUSION CRITERIA:

    1. Patients 18 years of age and older
    2. Patients undergoing a planned resection of hepatocellular carcinoma
    3. Patients must be willing to provide informed consent

EXCLUSION CRITERIA:

Patients with known inflammatory bowel disease or receiving systemic anti-inflammatory treatment.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:队列
  • 时间观点:预期

队列和干预

团体/队列
1/ Cohort 1
Subjects with hepatocellular carcinoma

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
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 ...
大体时间:1 year
Analysis of the interaction of tumors, immune responses and the gut microbiome
1 year

次要结果测量

结果测量
大体时间
Novel mechanisms how tumors may affect immune responses and gut microbiota
大体时间:1 year
1 year
Correlation between microbiome and patients' clinical outcome
大体时间:1 year
1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年11月6日

初级完成 (实际的)

2018年9月14日

研究完成 (实际的)

2018年9月14日

研究注册日期

首次提交

2015年11月6日

首先提交符合 QC 标准的

2015年11月6日

首次发布 (估计)

2015年11月9日

研究记录更新

最后更新发布 (实际的)

2018年9月20日

上次提交的符合 QC 标准的更新

2018年9月19日

最后验证

2018年9月14日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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