None listed
Conditions
Brief 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.
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
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).
Sponsors
University of New South Wales
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed