Gut Microbiota in People With Hepatocellular Carcinoma (HCC) | NCT02599909

Studies
Gut Microbiota in People With Hepatocellular Carcinoma (HCC)

NCT02599909

Sponsor

National Cancer Institute (NCI)

Status

Withdrawn

Last Update Posted

Sep 20, 2018Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Hepatocellular Carcinoma
Liver Cancer
Liver Cell Caricinoma
Liver Neoplasm

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
16-C-N012

Status Module

Record Verification Date

Sep 14, 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 6, 2015

Primary Completion Date

Sep 14, 2018Actual

Completion Date

Sep 14, 2018Actual

First Submitted Date

Nov 6, 2015

First Submission Date that Met QC Criteria

Nov 6, 2015

First Posted Date

Nov 9, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2018

Last Update Posted Date

Sep 20, 2018Actual

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
1/ Cohort 1		Subjects with hepatocellular carcinoma

Outcomes Module

Primary Outcomes

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 ...	Analysis of the interaction of tumors, immune responses and the gut microbiome	1 year

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tim F Greten, M.D.	National Cancer Institute (NCI)	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24547986	Background	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.
25079328	Background	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.

ID	Term
D006528	Carcinoma, Hepatocellular
D008113	Liver Neoplasms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type