Clinical trial · Observational
Gut Microbiota in People With Hepatocellular Carcinoma (HCC)
Gut Microbiota in Patients With HCC
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Liver Cell Caricinoma | — | UNRESOLVED | — |
| Liver Neoplasm | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- 1/ Cohort 1
- description
- Subjects with hepatocellular carcinoma
Primary outcomes (1)
- 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
- description
- Analysis of the interaction of tumors, immune responses and the gut microbiome
Secondary outcomes (2)
- measure
- Novel mechanisms how tumors may affect immune responses and gut microbiota
- timeFrame
- 1 year
- measure
- Correlation between microbiome and patients' clinical outcome
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
* 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.
References
Publications (3)
- BACKGROUNDGoel A, Gupta M, Aggarwal R. Gut microbiota and liver disease. J Gastroenterol Hepatol. 2014 Jun;29(6):1139-48. doi: 10.1111/jgh.12556. PMID 24547986
- BACKGROUNDQin 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. PMID 25079328
- BACKGROUNDDe 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. PMID 24581881