Genome Studies of Hepatocellular Carcinoma Developed in Hepatitis C Patients With Sustained Virological Response (HEPCASUS)

Karolinska Institute

Status: Completed

Conditions: Hepatitis C; Hepatocellular Carcinoma

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03254121

SAleman

Details and patient eligibility

About

In this international collaboration study, the research group will analyze somatic mutations of hepatocellular carcinoma (HCC) developed after sustained virological response (SVR) in patients treated with hepatitis C (HCV) therapy

Full description

Method Paired liver tissue samples will be collected from the tumour sections and also from the adjacent non-tumour tissues, for comparison in each individual. The tissues have been collected as part of routine clinical work/other studies, by liver biopsies or at liver resection/liver transplantation. Data regarding the patient characteristic will be collected. Whole genome sequencing analyses are planned to be performed.

Enrollment: 93 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with sustained virological response (SVR) after interferon (IFN)-containing or IFN-free treatment, and developed hepatocellular carcinoma (HCC)
• Available liver biopsies from hepatocellular carcinoma and non-HCC tissue

Exclusion criteria

• Co-infection with chronic hepatitis B (HBsAg positive) or HIV infection.
• Liver transplantation prior to treatment-start, leading to SVR.
• Patients with diagnosed HCC prior to treatment-start, leading to SVR.

Trial design

93 participants in 1 patient group

Patients with SVR and developed HCC

Description:

HCV patients with SVR and developed HCC plus available tissue from HCC