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

Completed

• Conditions: Hepatocellular Carcinoma; Hepatitis C

• Registration Number: NCT03254121
• Lead Sponsor: Karolinska Institutet

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-06-21
• Study First Submitted QC: 2017-08-15
• Study First Posted: 2017-08-18
• Primary Completion: 2020-09-01
• Study Completion: 2020-09-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden