Gut Microbiota in People With Hepatocellular Carcinoma (HCC)
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
地位
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
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
INCLUSION CRITERIA:
- Patients 18 years of age and older
- Patients undergoing a planned resection of hepatocellular carcinoma
- 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
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
出版物和有用的链接
一般刊物
- Goel A, Gupta M, Aggarwal R. Gut microbiota and liver disease. J Gastroenterol Hepatol. 2014 Jun;29(6):1139-48. doi: 10.1111/jgh.12556.
- Qin N, Yang F, Li A, Prifti E, Chen Y, Shao L, Guo J, Le Chatelier E, Yao J, Wu L, Zhou J, Ni S, Liu L, Pons N, Batto JM, Kennedy SP, Leonard P, Yuan C, Ding W, Chen Y, Hu X, Zheng B, Qian G, Xu W, Ehrlich SD, Zheng S, Li L. Alterations of the human gut microbiome in liver cirrhosis. Nature. 2014 Sep 4;513(7516):59-64. doi: 10.1038/nature13568. Epub 2014 Jul 23.
- De la Fuente M, Franchi L, Araya D, Diaz-Jimenez D, Olivares M, Alvarez-Lobos M, Golenbock D, Gonzalez MJ, Lopez-Kostner F, Quera R, Nunez G, Vidal R, Hermoso MA. Escherichia coli isolates from inflammatory bowel diseases patients survive in macrophages and activate NLRP3 inflammasome. Int J Med Microbiol. 2014 May;304(3-4):384-92. doi: 10.1016/j.ijmm.2014.01.002. Epub 2014 Feb 6. Erratum In: Int J Med Microbiol. 2015 May;305(3):434.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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