Hepatocellular Carcinoma Clinical Trial
Official title:
Gut Microbiota in Patients With HCC
Verified date | September 14, 2018 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 14, 2018 |
Est. primary completion date | September 14, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
- 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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National Cancer Institute (NCI) |
De la Fuente M, Franchi L, Araya D, Díaz-Jiménez D, Olivares M, Álvarez-Lobos M, Golenbock D, González MJ, López-Kostner F, Quera R, Núñez 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. — View 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. Review. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Novel mechanisms how tumors may affect immune responses and gut microbiota | 1 year | ||
Secondary | Correlation between microbiome and patients' clinical outcome | 1 year |
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