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

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

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Blood-Borne Infections Carcinoma Carcinoma, Hepatocellular Communicable Diseases Digestive System Diseases Digestive System Neoplasms Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska Institutet

Stockholm, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Characterisation of genomic mutations of HCC, developed in HCV patients with SVR

Time frame: 5 years

Genetic characteristics of HCCs will be compared to non-HCC tissue

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

AbbVie

Registry information

Acronym: HEPCASUS

Important dates

Study start: 2017
Primary completion: 2020
Study completion: 2020
First posted: Aug 18, 2017
Registry last updated: Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed