NCT03254121

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 18, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

3.7 years

First QC Date

June 21, 2017

Last Update Submit

February 16, 2021

Conditions

Hepatocellular CarcinomaHepatitis C

Keywords

Sustained virological responseWhole genome sequencing

Outcome Measures

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

    5 years

Study Arms (1)

Patients with SVR and developed HCC

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Please see eligibility criteria

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Liver tissue from HCC and adjacent non-HCC

MeSH Terms

Conditions

Carcinoma, HepatocellularHepatitis C

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis

Study Officials

  • Jan Bolinder, Prof

    Karolinska Institutet

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Assoc prof

Study Record Dates

First Submitted

June 21, 2017

First Posted

August 18, 2017

Study Start

January 1, 2017

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

February 18, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Individual IPD will not be shared with other researchers

Locations

SE(1)