Hepcasus
Research type
Research Study
Full title
Genome Studies of Hepatocellular carcinoma developed in hepatitis C patients with sustained virological response
IRAS ID
228223
Contact name
Liba Stone
Contact email
Sponsor organisation
Karolinska Instituet
Duration of Study in the UK
4 years, 11 months, 30 days
Research summary
Direct acting antivirals (DAA) have demonstrated greater efficacy in the management of patients with hepatitis C viral (HCV) infection; resulting in increasing numbers of patients with sustained virological response (SVR). However, the risk for development of hepatocellular carcinoma (HCC) in patients with SVR remains at 1%; in patients that present with HCV induced liver cirrhosis; post treatment with interferon. The management of HCC therefore presents a challenge.
This study is being undertaken to improve current knowledge of the molecular biology of HCC; to better understand the genetic alterations/mutations that give rise to HCC in patients after SVR; and determine if this knowledge will help identify patients at risk of developing HCC. The study also aims to analyse histopathological and immunohistochemical characteristics of HCCs developed in patients with SVR, the presence of fibrosis regression in these patients, and to analyse the survival after diagnosis of HCC.
Tissue will be collected retrospectively from diagnostic archive for those patients who have developed HCC after SVR. Patients will be divided into two groups: patients treated with/without interferon. Prospective collection of tissue from biopsy and normal tissue (blood in the absence of normal tissue) from newly diagnosed patients undergoing treatment, who are due a biopsy. Associated clinical data will also be collected.
This is a very select group of patients, hence an international collaboration has been arranged to facilitate recruitment. The collection of prospective samples will continue until 2021.
REC name
London - City & East Research Ethics Committee
REC reference
17/LO/1645
Date of REC Opinion
12 Oct 2017
REC opinion
Favourable Opinion