We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Christopher
Mysko
christopher.mysko@postgrad.manchester.ac.uk
Christopher
Mysko
christopher.mysko@postgrad.manchester.ac.uk
Dr
Varinder
Athwal
varinder.athwal@manchester.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Diseases of liverMalignant neoplasms of digestive organs
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Hepatocellular carcinoma (HCC) is the most common cancer affecting the liver. It is the third most common cause of cancer death. One of the risks for developing HCC is pre-existing liver disease and scarring of the liver, known as fibrosis and cirrhosis. Around 2 patients from 100 with cirrhosis will develop HCC every year. In early, curable stages, HCC can have no symptoms and so it is recommended that eligible patients are enrolled in a surveillance programme.
Currently patients at risk of developing HCC receive an ultrasound scan and blood test every 6 months. Unfortunately, even with current recommended surveillance more than half of patients are diagnosed with HCC at a stage where it cannot be cured. Our project looks to improve performance of testing, so we detect HCC at earlier and more curable stages.
This project will explore the use of an innovative solution, called Elecsys® GAAD, to improve early HCC detection. Elecsys® GAAD is CE marked for this intended use. It combines blood tests with gender and age in an algorithm. If raised, it can suggest the presence of HCC. It will be used alongside routine surveillance tests to see if it can help detect HCC earlier so patients have the best chance of surviving this cancer.
To make sure we are successful we have brought together specialists who know how to introduce new technologies in the NHS and experts who can work out the impact of new technologies on patients and healthcare services. We will work in partnership with patients and the public throughout the project to make sure the patient voice is heard and incorporated at all stages. We will share what we learn with the public and people who make decisions on whether new technologies are beneficial to patients and the NHS.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Validation of outcome measures;
You can take part if:
You may not be able to take part if:
• Liver cirrhosis Child-Pugh C not eligible for transplantation. • Age < 18 years. • Pregnancy/breast-feeding*. • Previous diagnosis of hepatocellular carcinoma. • Any patient who is unable to understand, retain and weigh information to make an informed decision. *Pregnant and breastfeeding females display a non-specific upregulation of AFP as unborn babies normally make alpha-fetoprotein (AFP), and it shows up in their mother's blood. Normally, in clinics, if this population is at risk of developing HCC, then the surveillance is imaging-based, and the pregnancy ultrasound is combined with the abdominal scan to survey them regularly. This is a low-risk population which was also part of our exclusion criteria for the GAAD development and validation prospective studies.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Christopher
Mysko
christopher.mysko@postgrad.manchester.ac.uk
Dr
Varinder
Athwal
varinder.athwal@manchester.ac.uk
Christopher
Mysko
christopher.mysko@postgrad.manchester.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by MANCHESTER UNIVERSITY NHS FOUNDATION TRUST and funded by NHS ENGLAND .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 56704
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
