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NCT03254121 Clinical Trial

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

Hepatocellular Carcinoma Clinical Trial

— HEPCASUS  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03254121
Other study ID # SAleman
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date September 1, 2020

Study information
Verified date February 2021
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 93
Est. completion date September 1, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Sweden Karolinska Institutet Stockholm

Sponsors (2)
Lead Sponsor Collaborator
Karolinska Institutet AbbVie

Country where clinical trial is conducted

Sweden, 

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