Clinical trial NCT04367805: COVID-19 Infection in Patients With Hepatocellular Carcinoma
Official title: Impact of COVID-19 Infection in Patients With Hepatocellular Carcinoma: An Ambispective Study Nestled in the CHIEF Cohort
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hepatocellular Carcinoma
COVID-19
Keywords: Hepatocellular Carcinoma
COVID-19
Coronavirus disease 2019-Incidence
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier-Universitaire Bondy
name: University Hospital, Bordeaux
name: Centre Hospitalier-Universitaire CLICHY
name: Centre Hospitalier Général CORBEIL-ESSONNE
name: CHU CRETEIL
name: University Hospital, Grenoble
name: University Hospital, Lille
name: Hospices Civils de Lyon
name: Poitiers University Hospital
name: Rennes University Hospital
name: University Hospital, Rouen
name: University Hospital, Toulouse
name: CHU VILLEJUIF
name: Central Hospital, Nancy, France
name: Centre Hospitalier Universitaire de Nice
name: University Hospital, Montpellier
First posted: 2020-04-29
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hepatocellular carcinoma population, both hospital and ambulatory

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of COVID-19 infection in patients with hepatocellular carcinoma in France
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References: