Hepatocellular CarcinomaRECARNCT03197155
Direct-acting Antivirals and Hepatocellular Carcinoma Recurrence
An observational study of Hepatocellular Carcinoma and Hepatitis C, run by Hospices Civils de Lyon.
Trial summary
Background and Aims: Arrival of direct-acting antiviral (DAA) agents against hepatitis C virus (HCV) with high-sustained virological response (SVR) rates and very few side effects has drastically changed the management of HCV infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Hepatitis C, Direct Acting Antivirals
- What is being tested?
- Direct Acting Antivirals against hepatitis C virus infection
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 31 Mar 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All HCV infected patients from the Department of Hepatology, Croix-Rousse Hospital, Lyon, France developing a first HCC and receiving or not a direct-acting antiviral combination therapy after HCC remission between January 2009 and March 2016 were considered.
Who may be able to join
- first HCC diagnosed by invasive or non-invasive criteria following the American Association for the Study of Liver Diseases (AASLD) guidelines during the study time horizon
- complete remission after hepatocellular carcinoma treatment defined by the European Association for the Study of the Liver (EASL) criteria as absence of residual tumor/complete necrosis at imaging one month after the end of hepatocellular carcinoma treatment
Who cannot join
- prior history of hepatocellular carcinoma before January 2009
- liver transplantation before hepatocellular carcinoma diagnosis
- presence of "non-characterized nodules" after hepatocellular carcinoma treatment at imaging
- history of direct-acting antivirals treatment before the first hepatocellular carcinoma diagnosis
- hepatic decompensation
- human immunodeficiency virus (HIV) coinfection.
About this study
Official title: Direct-acting Antiviral Therapy Decreases Hepatocellular Carcinoma Recurrence Rate in Cirrhotic Patients With Chronic Hepatitis C
Background and Aims: Arrival of direct-acting antiviral (DAA) agents against hepatitis C virus (HCV) with high-sustained virological response (SVR) rates and very few side effects has drastically changed the management of HCV infection. The impact of DAA exposure on hepatocellular carcinoma (HCC) recurrence after a first remission in patients with advanced fibrosis remains to be clarified.
Methods: 68 consecutive HCV patients with a first HCC diagnosis and under remission, subsequently treated or not with a DAA combination, were included. Clinical, biological, and virological data were collected at first HCC diagnosis, at remission and during the surveillance period.
- Being tested
- Direct Acting Antivirals against hepatitis C virus infection
- Medical subject headings
- Carcinoma, Hepatocellular, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Acting Antivirals against hepatitis C virus infectionDrug
The cohort includes cirrhotic patients infected with HCV and successfully treated for their first history of hepatocellular carcinoma. Some of these patients were treated with direct-acting antivirals for their HCV infection while the others did not receive any direct-acting antivirals treatment during the follow-up period.
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatocellular recurrence event
The primary outcome (hepatocellular recurrence event) is evaluated using imaging surveillance data at different time points during follow-up (every 3 months within the first year following HCC remission and every 3 to 6 months thereafter) after the first HCC remission.
Measured: From date of HCC remission until the date of HCC recurrence, assessed up to January 1st, 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start1 Jun 2016
- Primary completion31 Jan 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197155
- Sponsor's protocol ID
- 69HCL17_0400
- Acronym
- RECAR
- Status last verified
- Jun 2017
- First submitted
- 12 Jun 2017
- Last updated
- 23 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct-acting Antiviral Therapy Decreases Hepatocellular Carcinoma Recurrence Rate in Cirrhotic Patients With Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT03197155
- Acronym / sponsor ID
- RECAR / 69HCL17_0400
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 23 Jun 2017 (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 and Aims: Arrival of direct-acting antiviral (DAA) agents against hepatitis C virus (HCV) with high-sustained virological response (SVR) rates and very few side effects has drastically changed the management of HCV infection. The impact of DAA exposure on hepatocellular carcinoma (HCC) recurrence after a first remission in patients with advanced fibrosis remains to be clarified.
Methods: 68 consecutive HCV patients with a first HCC diagnosis and under remission, subsequently treated or not with a DAA combination, were included. Clinical, biological, and virological data were collected at first HCC diagnosis, at remission and during the surveillance period.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All HCV infected patients from the Department of Hepatology, Croix-Rousse Hospital, Lyon, France developing a first HCC and receiving or not a direct-acting antiviral combination therapy after HCC remission between January 2009 and March 2016 were considered.
Key inclusion criteria (2 listed)
- first HCC diagnosed by invasive or non-invasive criteria following the American Association for the Study of Liver Diseases (AASLD) guidelines during the study time horizon
- complete remission after hepatocellular carcinoma treatment defined by the European Association for the Study of the Liver (EASL) criteria as absence of residual tumor/complete necrosis at imaging one month after the end of hepatocellular carcinoma treatment
Key exclusion criteria (6 listed)
- prior history of hepatocellular carcinoma before January 2009
- liver transplantation before hepatocellular carcinoma diagnosis
- presence of "non-characterized nodules" after hepatocellular carcinoma treatment at imaging
- history of direct-acting antivirals treatment before the first hepatocellular carcinoma diagnosis
- hepatic decompensation
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 Antivirals against hepatitis C virus infectionThe cohort includes cirrhotic patients infected with HCV and successfully treated for their first history of hepatocellular carcinoma. Some of these patients were treated with direct-acting antivirals for their HCV infection while the others did not receive any direct-acting antivirals treatment during the follow-up period. | Drug | – |
Primary outcome
Hepatocellular recurrence event
Time frame: From date of HCC remission until the date of HCC recurrence, assessed up to January 1st, 2017
The primary outcome (hepatocellular recurrence event) is evaluated using imaging surveillance data at different time points during follow-up (every 3 months within the first year following HCC remission and every 3 to 6 months thereafter) after the first HCC remission.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Hepatitis C, run by Hospices Civils de Lyon.
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 6 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: finished, as of the sponsor's last update on 23 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatocellular recurrence event (time frame: From date of HCC remission until the date of HCC recurrence, assessed up to January 1st, 2017). 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 23 Jun 2017.