Clinical trial NCT02599909: Gut Microbiota in People With Hepatocellular Carcinoma (HCC)
Official title: Gut Microbiota in Patients With HCC
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hepatocellular Carcinoma
Liver Cancer
Liver Cell Caricinoma
Liver Neoplasm
Keywords: Tumor Microenvironment
100 Trillion Microbial Cells
Liver Tumors
Intestinal Microbiota
Immune Regulation
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2015-11-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: * 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.

Primary outcomes:
measure: 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 ...
timeFrame: 1 year
Secondary outcomes:
measure: Novel mechanisms how tumors may affect immune responses and gut microbiota
timeFrame: 1 year
measure: Correlation between microbiome and patients' clinical outcome
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: National Cancer Institute (NCI)
name: Tim F Greten, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.