Gut Microbiota in People With Hepatocellular Carcinoma (HCC)

September 19, 2018 updated by: 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.

Study Overview

Status

Withdrawn

Conditions

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.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1/ Cohort 1
Subjects with hepatocellular carcinoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 ...
Time Frame: 1 year
Analysis of the interaction of tumors, immune responses and the gut microbiome
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Novel mechanisms how tumors may affect immune responses and gut microbiota
Time Frame: 1 year
1 year
Correlation between microbiome and patients' clinical outcome
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 6, 2015

Primary Completion (Actual)

September 14, 2018

Study Completion (Actual)

September 14, 2018

Study Registration Dates

First Submitted

November 6, 2015

First Submitted That Met QC Criteria

November 6, 2015

First Posted (Estimate)

November 9, 2015

Study Record Updates

Last Update Posted (Actual)

September 20, 2018

Last Update Submitted That Met QC Criteria

September 19, 2018

Last Verified

September 14, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 999916012
  • 16-C-N012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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