REVISE HCC
Research type
Research Study
Full title
Real-world Elecsys® GAAD algorithm implementation and validation to improve surveillance and early detection of hepatocellular carcinoma
IRAS ID
324373
Contact name
Varinder Athwal
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 11 months, 30 days
Research summary
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.
REC name
London - Stanmore Research Ethics Committee
REC reference
23/LO/0851
Date of REC Opinion
31 Oct 2023
REC opinion
Further Information Favourable Opinion