Clinical Research Studies
The DeLIVER programme is running 3 clinical research studies (DELPHI, SELINA and PEARL) that aim to provide a better understanding on why changes within the liver (and in case of DELPHI also the bile ducts and pancreas) can lead to cancer and identify markers that detect liver cancer at the earliest stages when curative therapies may be applied. The clinical research studies recruit patients over the age of 18 years with liver conditions and/or liver cancer from NHS sites in the UK.
The DELPHI study is examining changes to the immune system that may predict the development of liver cancer. DELPHI investigators will collect blood and urine samples as well as small samples of cells directly from the liver. In the case of liver cells, this will be done using a technique called liver fine needle aspiration. This technique is low risk and has been successfully used in other studies.
The investigators will be recruiting 30 cancer patients (malignancy cohort) and 30 patients with other diseases of the liver who are at risk of developing cancer in the future (control cohort). Liver cells, blood, urine or bile samples from the different groups will be compared to identify changes specific to patients who have liver conditions that may indicate a risk of developing cancer in future. These changes could be in the types of white blood cells found within the liver, or, they may be in products secreted by liver or immune cells. In the latter case cells may release small pieces of their DNA into the blood or change the types of metabolic products that they produce.
DELPHI will be recruiting from one site, Oxford University Hospital NHS Foundation Trust, and will run actively for 5 years. Participants will be asked to attend up to 5 study visits where blood, urine, bile and optionally liver tissue via Fine-needle aspiration (FNA) will be collected. Those individuals who choose to undergo the FNA procedure will be asked to complete a questionnaire and will further receive a follow-up phone call to record any adverse events to the procedure.
The SELiNa Study aims to identify novel blood biomarkers and to use new imaging techniques to detect HCC at the earliest possible time points so that treatments that may cure HCC can be given.
The study will recruit 200 HCC patients with cirrhosis and 50 without cirrhosis from NHS sites throughout the UK. Blood, urine and liver tissue samples will be collected for analysis. In a subgroup of patients, Magnetic Resonance liver Imaging will be performed.
Participants will be followed-up via face-to-face visits and clinical records for up to 4 years. During this active follow-up period data will be collected covering their HCC, treatment and well-being either by online questionnaire, in person at a study visit coinciding with their clinical follow up appointment or over the phone at the anniversary of their enrolment.
A passive follow-up phase of at least 10 years will be conducted by the research teams by obtaining relevant medical information about participants from NHS digital. The findings of the SELiNa study will identify biomarkers that can be used to detect liver cancer at the earliest possible time, and so increase the survival rate of HCC.
The Pearl study aims to recruit 3000 people with liver cirrhosis caused by one of the underlying conditions of HCV, HBV, alcohol-related, NAFLD and haemochromatosis, who have never been diagnosed with HCC. Participants will be recruited from 40 NHS sites throughout the UK and will be asked to attend at least 3 study visits. Thereafter they will be followed up via their medical history for up to 10 years using NHS digital. Pearl will collect blood, urine, clinical and imaging data at the study visits.
It is expected that during the four-year follow-up period around 100 Pearl patients will be diagnosed with HCC. Thus, the study’s aim is to assess whether specific technologies (including genetic, protein and other biomarkers as well as imaging markers) for the early detection of HCC as identified in the related SELiNa study, are able to detect liver cancer at the earliest stages when curative therapies may be applied and to develop new prediction models to identify patients at most at risk of developing HCC.