Possible Differences in HCC Course Depending on DAA Treatment

May 11, 2022 updated by: Medical University of Warsaw

The Occurrence of HCC and Possible Differences in Its Course Depending on DAA Treatment

BACKGROUND It is estimated that around 71 milion people live with chronic hepatitis C virus (HCV) infection. This may lead to the development of liver cirrhosis and hepatocellular carcinoma (HCC). Liver cirrhosis is considered as one of the most common risk factors of hepatocellular carcinoma (HCC). HCC is seventh most common cancer worldwide. The treatment of HCV with direct-acting antivirals (DAAs) has led to the increase of sustained virological response (SVR) rates to more than 90%. It is suggested that the virus eradication reduces, but not eliminates the risk of HCC. This concerns especially patients with liver cirrhosis or previous HCC history. There are reports of early occurrence of HCC after the DAA treatment. Therefore, patients undergoing successful HCV treatment should be monitored for the possibility of hepatoccelular carcinoma occurrence.

AIM OF THE STUDY In this study the investigators aimed to assess the occurrence of HCC after direct acting antiviral HCV treatment and evaluate whether the course of HCC and liver function differ among the population of patients treated with DAAs and those who were not receiving the therapy with DAA.

MATERIAL AND METHODS This is the observative, cohort, retrospective study which will be performed in several clinical centres in Poland. The inclusion criteria are: hepatocellular carcinoma diagnosis, age >18 years old.

The investigators will collect both epidemiological (age, gender, comorbidities, alcohol abuse) and clinical data (serum bilirubin, alanine, aspartate aminotransferase, platelets, gammaglutamyltransferase, alkaline phosphatase and alpha-fetoprotein level, Child-Pugh and MELD score, imaging tests, liver biopsy and elastography, if performed).

In all patients, the HCV infection and co-infections will be assessed. In those who underwent the DAA treatment, the composition of the therapy and response to the treatment will be evaluated.

Statistical analysis will be performed in subgroups of patients undergoing DAA treatment and without the therapy. The distribution of continuous variables will be analysed by the Shapiro-Wilk test. Quantitative data will be analysed using the Mann-Whitney U test or Kruskal-Wallis ANOVA when appropriate. Qualitative data will be compared using the χ² test or the Fisher exact test. Correlations between quantitative variables will be assessed using the Spearman correlation coefficient. P value will be set at <0.05.

FUNDING:

No remuneration is provided for participation in the study

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 02-091
        • Recruiting
        • Medical University of Warsaw
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The participants will be selected from several clinical centres in Poland.

Description

Inclusion Criteria:

  • hepatocellular carcinoma diagnosis
  • age >18 years old

Exclusion Criteria:

  • age <18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients diagnosed with HCC after receiving direct acting antiviral HCV treatment
In this group there will be patients with the diagnosis of hepatocellular carcinoma, who underwent direct acting antiviral treatment. We will collect both epidemiological (age, gender, comorbidities, alcohol abuse) and clinical data (serum bilirubin, alanine, aspartate aminotransferase, gammaglutamyltransferase, alkaline phosphatase and alpha-fetoprotein level, Child-Pugh and MELD score, imaging tests, liver biopsy and elastography, if performed). The HCV infection and co-infections will be assessed and also the composition of therapy and the response to treatment will be evaluated.
Drug: Direct Acting Antivirals
Our observational study will assess the exposure to direct acting antivirals - the specific drugs, dose, duration of the therapy and the effect of the treatment.
Patients diagnosed with HCC who were not receiving direct acting antiviral HCV treatment
In this group there will be patients with the diagnosis of hepatocellular carcinoma, who were not receiving direct acting antiviral treatment. We will collect both epidemiological (age, gender, comorbidities, alcohol abuse) and clinical data (serum bilirubin, alanine, aspartate aminotransferase, gammaglutamyltransferase, alkaline phosphatase and alpha-fetoprotein level, Child-Pugh and MELD score, imaging tests, liver biopsy and elastography, if performed). The HCV infection and co-infections will also be assessed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The occurrence of HCC after direct acting antiviral HCV treatment.
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
The comparison of the course of HCC among the population of patients treated with DAAs and those who were not receiving the therapy.
Time Frame: 1 year
1 year
The difference in liver function tests among the population of patients treated with DAAs and those who were not receiving the therapy.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 10, 2022

Primary Completion (ANTICIPATED)

October 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

September 27, 2021

First Submitted That Met QC Criteria

May 11, 2022

First Posted (ACTUAL)

May 17, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2022

Last Update Submitted That Met QC Criteria

May 11, 2022

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKBE/118/2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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