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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03254121

Acronym

HEPCASUS

Enrollment

Registered

2017-08-18

Start date

2017-01-01

Completion date

2020-09-01

Last updated

2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Hepatocellular Carcinoma

Keywords

Sustained virological response, Whole genome sequencing

Brief summary

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

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Characterisation of genomic mutations of HCC, developed in HCV patients with SVR	5 years	Genetic characteristics of HCCs will be compared to non-HCC tissue

Countries

Sweden

Outcome results