The Microbiome in Liver Disease and Liver Cancer

Not Applicable

Recruiting

• Conditions: iver Disease; Liver Cirrhosis; Liver Cancer; Liver Disease; Cancer - Liver

• Registration Number: ACTRN12623000115639
• Lead Sponsor: niversity of New South Wales

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-03
• Last Update Posted: 13 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Patients over the age of 18; patients with chronic liver disease and primary liver cancer (HCC); patients under the care of the investigators of this study (or their associates) who routinely visit study sites for treatment or care; patients willing to provide informed consent.

Exclusion Criteria

Subjects aged < 18 years; other primary liver cancers (e.g., mixed hepatocellular carcinoma and cholangiocarcinoma); known gastrointestinal disease; previous gastrointestinal surgery.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identify compositional shifts in the microbiome of cirrhotic participants with liver cancer development using shotgun metagenomic sequencing of oral and stool samples. [Baseline followed by every 6 months until the onset of liver cancer. ];Identify functional shifts in the microbiome of cirrhotic participants with liver cancer development by performing metabolomic analyses (NMR spectroscopy, ultra-performance liquid-chromatography mass spectrometry) on blood and stool samples. [Baseline followed by every 6 months until the onset of liver cancer. ];Identify a microbial-related shift in the cytokine milieu in participants that develop liver cancer using the Bio-Plex Pro human cytokine assay kit on blood samples. [Baseline followed by every 6 months until the onset of liver cancer. ]

Secondary Outcome Measures

Name	Time	Method
il.[Nil.]