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COVID-19 Infection in Patients With Hepatocellular Carcinoma (COVID19-CHIEF)

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ClinicalTrials.gov Identifier: NCT04367805
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : April 29, 2020
Sponsor:
Collaborators:
Centre Hospitalier-Universitaire Bondy
University Hospital, Bordeaux
Centre Hospitalier-Universitaire CLICHY
Centre Hospitalier Général CORBEIL-ESSONNE
CHU CRETEIL
University Hospital, Grenoble
University Hospital, Lille
CHU LYON
Poitiers University Hospital
Rennes University Hospital
University Hospital, Rouen
University Hospital, Toulouse
CHU VILLEJUIF
Central Hospital, Nancy, France
Centre Hospitalier Universitaire de Nice
University Hospital, Montpellier
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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

Condition or disease Intervention/treatment
Hepatocellular Carcinoma COVID-19 Diagnostic Test: nasopharyngeal Covid 19 RT-PCR

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Impact of COVID-19 Infection in Patients With Hepatocellular Carcinoma: An Ambispective Study Nestled in the CHIEF Cohort
Actual Study Start Date : April 27, 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Intervention Details:
  • Diagnostic Test: nasopharyngeal Covid 19 RT-PCR
    nasopharyngeal Covid 19 RT-PCR


Primary Outcome Measures :
  1. Incidence of COVID-19 infection in patients with hepatocellular carcinoma in France [ Time Frame: 6 months ]
    Incidence of COVID-19 infection in patients with hepatocellular carcinoma in France



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
hepatocellular carcinoma population, both hospital and ambulatory
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04367805


Contacts
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Contact: Eric NGUYEN KHAC, Pr (33)3 22 08 88 51 nguyen-khac.eric@chu-amiens.fr
Contact: Olivier GANRY, Pr (33)3 22 08 83 76 ganry.olivier@chu-amiens.fr

Locations
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France
CHU Amiens Recruiting
Amiens, France, 80480
Contact: Eric NGUYEN KHAC, Pr    (33)3 22 08 88 51    nguyen-khac.eric@chu-amiens.fr   
Contact: Olivier Ganry, Pr    (33)322668193    ganry.olivier@chu-amiens.fr   
Principal Investigator: Nathalie GANNE-CARRIE, Pr         
Principal Investigator: Jean-Frédéric BLANC, MD         
Principal Investigator: Mohamed BOUATTOUR, MD         
Principal Investigator: Aurore BARON, MD         
Principal Investigator: Giuliana AMADDEO, MD         
Principal Investigator: Thomas DECAENS, Pr         
Principal Investigator: Philippe MATHURIN, Pr         
Principal Investigator: Philippe MERLE, Pr         
Principal Investigator: Christine SILVAIN, Pr         
Principal Investigator: Julien EDELINE, MD         
Principal Investigator: Pierre MICHEL, Pr         
Principal Investigator: Jean-Marie PERON, Pr         
Principal Investigator: Éric VIBERT, Pr         
Principal Investigator: Jean Pierre BRONOWICKI, Pr         
Principal Investigator: Rodolphe ANTY, Pr         
Principal Investigator: Eric ASSENAT, Pr         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Centre Hospitalier-Universitaire Bondy
University Hospital, Bordeaux
Centre Hospitalier-Universitaire CLICHY
Centre Hospitalier Général CORBEIL-ESSONNE
CHU CRETEIL
University Hospital, Grenoble
University Hospital, Lille
CHU LYON
Poitiers University Hospital
Rennes University Hospital
University Hospital, Rouen
University Hospital, Toulouse
CHU VILLEJUIF
Central Hospital, Nancy, France
Centre Hospitalier Universitaire de Nice
University Hospital, Montpellier
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT04367805    
Other Study ID Numbers: PI2020_843_0042
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
Hepatocellular Carcinoma
COVID-19
Coronavirus disease 2019-Incidence
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases