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CompletedNCT03254121HEPCASUSUpdated Feb 18, 2021

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

An observational study in Hepatocellular Carcinoma and Hepatitis C, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-18.

Sponsored by Karolinska Institutet · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
93
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Hepatocellular Carcinoma
  • Hepatitis C

Keywords

  • Sustained virological response
  • Whole genome sequencing
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Please see eligibility criteria

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

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.
04

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
93 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Patients with SVR and developed HCC

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

05

What researchers measure

Primary outcomes

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

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

    Time frame: 5 years

06

Study locations

1 site
  • Karolinska Institutet
    Stockholm, Sweden
07

References and documents

Individual participant data

Plan to share: No — Individual IPD will not be shared with other researchers

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03254121
Lead sponsor
Karolinska Institutet
Collaborators
AbbVie
Responsible party
Soo Aleman (MD, PhD, Assoc prof, Karolinska Institutet) — Principal investigator
First posted
Aug 18, 2017
Start date
Jan 1, 2017
Primary completion
Sep 1, 2020
Completion
Sep 1, 2020
Last update
Feb 18, 2021

Study contacts

Jan Bolinder, Prof
study chair · Karolinska Institutet

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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