MedTrace Logo

Possible Differences in HCC Course Depending on DAA Treatment

NCT05376943 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2022-05-17

No results posted yet for this study

Summary

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

Conditions

  • Carcinoma, Hepatocellular
  • Hepatitis C Virus Infection, Response to Therapy of
  • Drug Effect
  • Drug Side Effect
  • Hepatitis C, Chronic
  • Liver Cirrhosis

Interventions

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.

Sponsors & Collaborators

  • Medical University of Warsaw

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-10
Primary Completion
2022-10-31
Completion
2022-12-31
FDA Drug
Yes

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05376943 on ClinicalTrials.gov