COVID-19 Infection in Patients With Hepatocellular Carcinoma (NCT04367805) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
COVID-19 Infection in Patients With Hepatocellular Carcinoma
France23 participantsStarted 2020-05-22
Plain-language summary
Since December 2019, a new disease named COVID-19 linked to a new coronavirus, SARS-CoV2 has emerged in China in the city of Wuhan, Hubei province, spreading very quickly to all 5 continents, and responsible for a pandemic. France is the third most affected country in Europe after Italy and Spain. Groups of patients at a higher risk of developing a severe form of COVID-19 have been defined: this include patients with immunosuppressive disease as cancer or patients with advanced cirrhosis of the liver. Coronavirus liver injury had been described with SARS-CoV 1 and MERS-CoV. There is no data on liver damage associated with COVID-19 infection for compensated or decompensated cirrhotic patients. The objectives of this project are to estimate the incidence of COVID-19 in hepatocellular carcinoma population, both hospital and ambulatory, and to study the impact on the frequency of severe forms, the prognosis, but also liver function, and the management of hepatocellular carcinoma, in this context of pandemic
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with CHC and included in the French national prospective cohort CHIEF
* Hospital and ambulatory patients
* Infection confirmed by COVID-19 defined by a positive nasopharyngeal PCR or if PCR COVID-19 negative : CT showing COVID-19 compatible pneumonia
* Suspected COVID-19 infection, not confirmed by COVID-19 PCR or chest CT, with no other known cause of acute pneumonia.
Exclusion Criteria:
* Patient refusal
* Influenza only, confirmed by a diagnostic test
* Other proven causes of pneumonia and absence of COVID-19
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is observational and tracking COVID-19 infection rates in hepatocellular carcinoma patients in France rather than testing a new treatment, what does participation actually involve for me — would I be doing anything differently from my usual care?
2Given that this trial is no longer actively recruiting but is still running, does that mean any data collected could still be relevant to understanding how COVID-19 affects my situation with hepatocellular carcinoma, and should that influence any precautions I take?
3Because this study is specifically looking at how often HCC patients in France get COVID-19, does the existing data so far suggest that my liver cancer diagnosis puts me at meaningfully higher risk from COVID-19 compared to the general population?
4Would participating in or being aware of this study change any of the monitoring or follow-up appointments in my current hepatocellular carcinoma treatment plan, or would everything stay the same?
5Are there other active studies or updated guidelines specifically addressing COVID-19 risk management for hepatocellular carcinoma patients that my care team is following, given that this study is no longer enrolling new participants?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of COVID-19 infection in patients with hepatocellular carcinoma in France