Hepatocellular Carcinoma Clinical Trial
Official title:
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.
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.
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