IC3 Trial: A Randomised Control Trial aiming to improve early diagnosis of liver cancer and improving patient health outcomes
The liver is the largest organ in the human body, it plays a key role in filtering blood, however, many Australians do not know if their liver is healthy. Undetected liver disease may lead to liver changes, which can lead to liver scarring (called cirrhosis). Cirrhosis is a major risk factor for liver cancer, which, although rare, is increasing globally and in Australia, and has low survival rates (21%) (1).
This trial, co- led by Prof Leon Adams at the University of Western Australia, and Prof Jon Emery, is an Australia-wide multi-centre randomised controlled trial randomizing 2,804 adults aged 45-75 years with risk factor(s) for chronic liver disease. Patients are recruited from regional and urban General Practices and will be randomly assigned to a cirrhosis detection pathway or usual care. The primary outcome is the proportion of patients with newly diagnosed cirrhosis undergoing hepatocellular carcinoma (HCC) surveillance at 12 months. We will compare the diagnostic characteristics, patient reported outcomes, and cost-effectiveness of different cirrhosis detection strategies that lead to HCC surveillance, to provide the optimal evidence and rapid implementation into clinical care. The project will utilise linked data from several administrative datasets including MBS and PBS data as well as state-specific datasets.
Prof Leon Adams, Hepatologist, University of Western Australia
Herman Prof Jon Emery, Academic GP, University of Melbourne
Dr. Charlotte Hespe, Academic GP, University of Notre Dame Australia
Dr. Riitta Partanen, Academic GP, University of Queensland
Dr. Andrew Kirke, Academic GP, University of Western Australia
Dr. Deborah de Guingand, IC3 National Manager, University of Melbourne
Ms. Tarryn Miles, Research Assistant, University of Melbourne
Ms. Katerina Piakis, Research Assistant, University of Melbourne
Ms. Sophie Frear, Research Assistant, University of Western Australia
Ms. Holly Napret, Research Assistant, University of Western Australia
Prof Alex Thompson, Hepatologist, St Vincent’s Hospital Melbourne and University of Melbourne
Prof Christopher Reid, Epidemiologist, Curtin University
Prof Gary Jeffery, Hepatologist, Sir Charles Gairdner Hospital and University of Western Australia
Dr. Michael Wallace, Hepatologist, Sir Charles Gairdner Hospital and University of Western Australia
A/Prof Simone Strasser, Hepatologist, Royal Prince Alfred Hospital and University of Sydney
Darrell Crawford, Hepatologist, University of Queensland
A/Prof Louisa Gordon, Health Economist, QIMR Berghofer Medical Research Institute
Dr. Nicole Allard, Academic GP, University of Melbourne
A/Prof Claudia Rutherford, Patient Reported Outcomes, University of Sydney
This is a MRFF-EPCDRI-funded grant for improving diagnosis in cancers with low survival rates.
Early detection of liver fibrosis and cirrhosis is key to identifying people who require targeted surveillance to detect liver cancer early. Liver cancer can develop with little or no symptoms with late presentation impacting treatment success and survival from this cancer. A feasible, easy and cost-effective cirrhosis screening pathway in primary care could detect changes early, reducing the incidence of liver cancer therefore improving overall survival rates.
The IC3 trial will provide the first comprehensive assessment of liver health in an ‘at risk’ general population group for liver disease, placing them into appropriate surveillance pathways. The IC3 trial will provide evidence to policy makers as to whether a change in clinical practice guidelines is warranted in Australian primary health care settings.
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