Carcinoma, HepatocellularNCT05376943
Possible Differences in HCC Course Depending on DAA Treatment
An observational study of Carcinoma, Hepatocellular and Hepatitis C Virus Infection, Response to Therapy of, run by Medical University of Warsaw at 1 site in Poland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Carcinoma, Hepatocellular, Hepatitis C Virus Infection, Response to Therapy of, Drug Effect
- What is being tested?
- Direct Acting Antivirals
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 10 May 2022to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The participants will be selected from several clinical centres in Poland.
Who may be able to join
- hepatocellular carcinoma diagnosis
- age >18 years old
Who cannot join
- age <18 years old
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Warsaw
Warsaw, Masovian Voivodeship, 02-091
Agnieszka J Lembas, +48609751306, a.bartosiewicz@hotmail.com
About this study
Official title: 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.
Read more
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
- Being tested
- Direct Acting Antivirals
- Keywords
- hepatocellular carcinoma, hepatitis C, direct-acting antiviral agents
- Medical subject headings
- Carcinoma, Hepatocellular, Hepatitis C, Drug-Related Side Effects and Adverse Reactions, Hepatitis C, Chronic, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Acting AntiviralsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Direct Acting Antivirals | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of HCC after direct acting antiviral HCV treatment.
Measured: 1 year
Secondary outcomes (2)
The comparison of the course of HCC among the population of patients treated with DAAs and those who were not receiving the therapy.
Measured: 1 year
The difference in liver function tests among the population of patients treated with DAAs and those who were not receiving the therapy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start10 May 2022
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376943
- Sponsor's protocol ID
- AKBE/118/2021
- Status last verified
- Sep 2021
- First submitted
- 27 Sep 2021
- Last updated
- 17 May 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Occurrence of HCC and Possible Differences in Its Course Depending on DAA Treatment
- ClinicalTrials.gov ID
- NCT05376943
- Acronym / sponsor ID
- AKBE/118/2021
- Conditions
- Carcinoma, Hepatocellular, Hepatitis C Virus Infection, Response to Therapy of, Drug Effect, Drug Side Effect, Hepatitis C, Chronic, Liver Cirrhosis
- Keywords
- hepatocellular carcinoma, hepatitis C, direct-acting antiviral agents
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with HCC after receiving direct acting antiviral HCV treatment | – | Drug: Direct Acting AntiviralsIn 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. |
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants will be selected from several clinical centres in Poland.
Key inclusion criteria (2 listed)
- hepatocellular carcinoma diagnosis
- age >18 years old
Key exclusion criteria (1 listed)
- age <18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct Acting AntiviralsOur observational study will assess the exposure to direct acting antivirals - the specific drugs, dose, duration of the therapy and the effect of the treatment. | Drug | Patients diagnosed with HCC after receiving direct acting antiviral HCV treatment |
Primary outcome
The occurrence of HCC after direct acting antiviral HCV treatment.
Time frame: 1 year
2 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
Related trials for Carcinoma, Hepatocellular
Not yet recruitingPhase 1
Study of ACC-1898 in Adult Participants With Advanced Solid Tumors
Hepatocellular Carcinoma, Renal Cell Carcinoma
RecruitingObservational study
Observational Study Protocol: LIVER-R
Hepatobiliary Cancers
Enrolling by invitationPhase 3
Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored Study
Cancer, Renal Cell Carcinoma (RCC)
Active, not recruiting
BioPearl™ Microspheres Loaded With Doxorubicin for the Treatment of Unresectable Hepatocellular Carcinoma (HCC)
Hepatocellular Carcinoma Non-resectable
Active, not recruitingPhase 1
Nivolumab With or Without Relatlimab for Patients With Potentially Resectable Hepatocellular Carcinoma
Hepatocellular Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Hepatocellular and Hepatitis C Virus Infection, Response to Therapy of, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Agnieszka J Lembas (+48609751306, a.bartosiewicz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of HCC after direct acting antiviral HCV treatment. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.