RecruitingACTRN12623000115639

The Microbiome in Liver Disease and Liver Cancer

The Role of the Microbiome in the Pathogenesis of Liver Disease and Liver Cancer

Sponsor

University of New South Wales

Enrollment

1,000 participants

Start Date

Nov 22, 2022

Study Type

Observational

Conditions

Liver Cancer Liver Cirrhosis Liver Disease

Summary

This study aims to identify one or more liver cancer specific microbial based biomarkers using a range of blood, stool (faecal) and oral samples from people who have a confirmed diagnosis of primary liver cancer and people who are at high risk of developing liver cancer due to chronic liver disease. Who is it for? You may be eligible for this study if you are an adult aged 18 years or older who has been diagnosed with chronic liver disease and/or primary liver cancer. Study details All participants who choose to enrol in this study will be asked to provide blood, stool and oral samples at 6 month intervals for up to five years post-enrolment. The study investigators will aim to collect these samples during a routine scheduled clinic visit so that participants do not need to attend additional study visits. It is hoped this research will identify and validate a liver cancer specific biomarker model for early diagnosis of liver cancer. If successful, tests for identified biomarkers may then be used to diagnose liver cancer earlier in at-risk patients, which may lead to better outcomes for future liver cancer patients.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Liver cancer is a serious and often late-diagnosed disease. People with chronic liver disease — such as cirrhosis from hepatitis B, hepatitis C, fatty liver disease, or alcohol — are at significantly higher risk of developing primary liver cancer. Catching it early dramatically improves the chance of successful treatment. This study aims to find biological markers — measurable signals in blood, stool, and saliva — that are specific to liver cancer, so it can be detected earlier and more reliably. Participants will provide blood, stool, and oral samples every 6 months for up to 5 years, with collections timed to coincide with their usual clinic visits so no extra trips are needed. Researchers will analyse samples from people who already have liver cancer and people at high risk who haven't developed it yet, comparing the two groups to identify cancer-specific patterns. You may be eligible if you are 18 or older, have chronic liver disease and/or primary liver cancer (hepatocellular carcinoma), and are under the care of a doctor at one of the study sites. People with other types of primary liver cancer, known gastrointestinal disease, or previous gastrointestinal surgery are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

We are studying changes in the microbiome and metabolome of patients with liver disease. Participants enrolled in the study will provide blood, stool and oral samples every 6 months when attending routine clinic visits. A key component of the study is the collection of samples from participants with liver cirrhosis until the development of liver cancer. For this reason, participants will be enrolled in the study for a period of 5 years. For oral and stool samples, participants will receive a kit to take home with instructions on how to collect the samples. For oral sample collection, the kit will consist of a swab and a collection tube. Participants will be asked to brush the inside surfaces of their mouth with the swab. For stool sample collection, the provided kit contains a ColOff® specimen collector, which is a plastic sleeve for the toilet seat that allows hygienic collection of stool. Two validated surveys on physical activity and diet will be administered via REDCap every 6 months. The Physical Activity Scale for the Elderly (PASE) will be used to assess physical activity of recruited participants. The Australian Eating Survey Food Frequency Questionnaire (AES FFQ) will be used to collect diet-related data to assess intake of the major food groups. The surveys can be completed at home and should not take longer than a total of 30 minutes to complete. Participating sites for the study include St George, Royal North Shore Hospital, Nepean, John Hunter and three sites in Victoria (The Alfred, St Vincent’s and Austin Health).