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

NCT ID: NCT03254121

Last Updated: 2021-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

93 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2020-09-01

Brief Summary

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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

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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.

Conditions

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Hepatocellular Carcinoma Hepatitis C

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Patients with SVR and developed HCC

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Soo Aleman

MD, PhD, Assoc prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan Bolinder, Prof

Role: STUDY_CHAIR

Karolinska Institutet

Locations

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Karolinska Institutet

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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SAleman

Identifier Type: -

Identifier Source: org_study_id

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