Clinical trial NCT04397575: The GCO-002 CACOVID-19 Cohort: a French Nationwide Multicenter Study of COVID-19 Infected Cancer Patients
Official title: Cohorte Non Interventionnelle Ambispective Nationale Multicentrique de Patients Suivis Pour Cancer et infectés Par le SARS-CoV-2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
COVID
Solid Tumor
Social Inequality
French National Cohort
Chemotherapy
Immunotherapy
Surgery
Radiotherapy
Keywords: cancer
COVID
solid tumor
social inequality
french national cohort
chemotherapy
Immunotherapy
surgery
radiotherapy
Lead sponsor: Federation Francophone de Cancerologie Digestive
Sponsor class: OTHER
Collaborators: name: ARCAGY/ GINECO GROUP
name: GERCOR - Multidisciplinary Oncology Cooperative Group
name: GORTEC
name: Intergroupe Francophone de Cancerologie Thoracique
name: Association de Neuro-Oncologues d'Expression Francaise
First posted: 2020-05-21
Enrollment: 1523
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient undergoing treatment or under surveillance or recently diagnosed and who has not yet started treatment for cancer at one of the following locations : digestive (esophagus, stomach, colorectal, small intestine, pancreas, biliary tract, Vater's ampulla, liver, GIST, neuroendocrine tumour, anal canal, primary peritoneum, appendix), thoracic (non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), mesothelioma), head and neck (oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, salivary glands, sinus), gynecological (breast, ovary, cervix, endometrium, vulva), central nervous system, dermatological, urological (prostate, kidney, bladder and upper urinary tract, external genitals)

Brief summary: Since December 2019, China and then the rest of the world have been affected by the rapid development of a new coronavirus, SARS-CoV-2 (severe acute respiratory syndrome corona virus 2). The disease caused by this coronavirus (COVID-19), which is transmitted by air via droplets, is potentially responsible for a severe respiratory syndrome but also for a multivisceral deficiency that can lead to death.

Cancer patients are generally more susceptible to infections than people without cancer due to immunosuppression caused by their tumor disease and/or conventional anti-cancer treatments used such as cytotoxic chemotherapy, several targeted therapies, radiotherapy or recent surgery. These patients may therefore be at particular risk for COVID-19.

This is suggested by the very first analysis on the subject, which reports data from the Chinese prospective database of 2007 patients with proven COVID-19 infection in 575 hospitals in 31 Chinese provinces. The authors of this publication conclude with 3 measures to be proposed to patients undergoing cancer follow-up: 1/ consider postponing adjuvant chemotherapy or surgery in the case of localized and stable cancer, 2/ reinforce protective measures for these patients, and 3/ monitor very closely and treat these patients more intensively when they have a COVID-19.

However, the increased risk of SARS-CoV-2 infection and severe forms of COVID-19 in cancer patients suggested by this first study remains to be demonstrated given its limitations, already highlighted by other authors. Indeed, the number of patients is small and the population of cancer patients is very heterogeneous, with in particular 12 patients out of 16 who had recovered from initial cancer treatments (therefore without immunosuppression), half of whom had a disease course of more than 4 years.

Nevertheless, a second Chinese study has just recently been published, reporting COVID-19 data among 1524 cancer patients admitted between December 30, 2019 and February 17, 2020 in the Department of Radiotherapy and Medical Oncology of the University Hospital of Wuhan, the source city of the COVID-19 epidemic. Although the rate of CoV-2 SARS infection was lower than that reported in the first study, it was still 0.79% (n=12), which is much higher than the rate of COVID-19 diagnosed in Wuhan City during the same period (0.37%, 41 152/11 081 000). Again, lung cancer was the main tumour location observed in 7 patients (58%), of which 5 (42%) were undergoing chemotherapy +/- immunotherapy. Three deaths (25%) were reported. Patients over 60 years of age with lung cancer had a higher incidence of COVID-19 (4.3% vs. 1.8%). Thus, it appears that the risk of COVID-19 is actually increased in cancer patients, although again, less than half of the patients with lung cancer had a higher incidence of COVID-19.

Moreover, two more recent studies performed in patients treated in Hubei Province of China and in New-York city found that patients with cancer had significantly increased risk of death compared to non-cancer COVID-19 patients, especially patients with metastatic cancer and those who had recent surgery.

Therefore, many questions remain to date on the level of risk and the severity of COVID-19 in patients with active cancer, in particular those under anti-cancer treatment and in patients recently operated for localized cancer.

Detailed description: Since December 2019, China and then the rest of the world have been affected by the rapid development of a new coronavirus, SARS-CoV-2 (severe acute respiratory syndrome corona virus 2). The disease caused by this coronavirus (COVID-19), which is transmitted by air via droplets, is potentially responsible for a severe respiratory syndrome but also for a multivisceral deficiency that can lead to death.

In less than 3 months, the COVID-19 epidemic has already affected more than 440,000 persons and has been responsible for more than 20,000 deaths worldwide.

Cancer patients are generally more susceptible to infections than people without cancer due to immunosuppression caused by their tumor disease and/or conventional anti-cancer treatments used such as cytotoxic chemotherapy, several targeted therapies, radiotherapy or recent surgery. These patients may therefore be at particular risk for COVID-19.

This is suggested by the very first analysis on the subject, which reports data from the Chinese prospective database of 2007 patients with proven COVID-19 infection in 575 hospitals in 31 Chinese provinces. After exclusion of 417 cases without sufficient available clinical data, 1590 cases of patients infected with COVID-19 were analysed, of which 18 (1%) had a personal history of cancer. This prevalence was higher than that of COVID-19 in the general Chinese population since the beginning of the epidemic (0.29%). Lung cancer (n=5, 28%) and colorectal cancer (n=5, 28%) were the 2 most common cancers. Four (25%) of the 16 patients for whom treatment was known had received chemotherapy or had surgery in the month prior to COVID-19 infection, while the majority (n=12, 75%) were patients in remission or cured of their cancer after primary surgery. Compared to patients without cancer, patients with cancer were older (63 years vs. 48 years) and had a more frequent history of smoking (22% vs. 7%). Most importantly, patients with cancer had more severe forms of COVID-19 than patients without cancer (7/18 or 39% vs. 124/1572 or 8%, p=0.0003). Patients who had chemotherapy or surgery in the month preceding the diagnosis of COVID-19 had a significantly increased risk of the severe form (3/4 or 75% vs. 6/14 or 43%), which was confirmed in multivariate analysis after adjustment on other risk factors such as age, smoking and other comorbidities, with a relative risk of 5.34 (95% CI: 1.80-16.18;p=0.0026). Finally, patients with cancer deteriorated more rapidly than patients without cancer (13 days vs. 43 days, p\<0.0001). The authors of this publication conclude with 3 measures to be proposed to patients undergoing cancer follow-up: 1/ consider postponing adjuvant chemotherapy or surgery in the case of localized and stable cancer, 2/ reinforce protective measures for these patients, and 3/ monitor very closely and treat these patients more intensively when they have a COVID-19.

However, the increased risk of SARS-CoV-2 infection and severe forms of COVID-19 in cancer patients suggested by this first study remains to be demonstrated given its limitations, already highlighted by other authors. Indeed, the number of patients is small and the population of cancer patients is very heterogeneous, with in particular 12 patients out of 16 who had recovered from initial cancer treatments (therefore without immunosuppression), half of whom had a disease course of more than 4 years.

Nevertheless, a second Chinese study has just recently been published, reporting COVID-19 data among 1524 cancer patients admitted between December 30, 2019 and February 17, 2020 in the Department of Radiotherapy and Medical Oncology of the University Hospital of Wuhan, the source city of the COVID-19 epidemic. Although the rate of CoV-2 SARS infection was lower than that reported in the first study, it was still 0.79% (n=12), which is much higher than the rate of COVID-19 diagnosed in Wuhan City during the same period (0.37%, 41 152/11 081 000). Again, lung cancer was the main tumor location observed in 7 patients (58%), of which 5 (42%) were undergoing chemotherapy +/- immunotherapy. Three deaths (25%) were reported. Patients over 60 years of age with lung cancer had a higher incidence of COVID-19 (4.3% vs. 1.8%). Thus, it appears that the risk of COVID-19 is actually increased in cancer patients, although again, less than half of the patients with lung cancer had a higher incidence of COVID-19.

Moreover, two more recent studies performed in patients treated in Hubei Province of China and in New-York city found that patients with cancer had significantly increased risk of death compared to non-cancer COVID-19 patients, especially patients with metastatic cancer and those who had recent surgery.

Therefore, many questions remain to date on the level of risk and the severity of COVID-19 in patients with active cancer, in particular those under anti-cancer treatment and in patients recently operated for localized cancer.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Patient undergoing treatment or under surveillance or recently diagnosed and who has not yet started treatment for cancer at one of the following locations : digestive (esophagus, stomach, colorectal, small intestine, pancreas, biliary tract, Vater's ampulla, liver, GIST, neuroendocrine tumour, anal canal, primary peritoneum, appendix), thoracic (non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), mesothelioma), head and neck (oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, salivary glands, sinus), gynecological (breast, ovary, cervix, endometrium, vulva), central nervous system, dermatological, urological (prostate, kidney, bladder and upper urinary tract, external genitals)
* Patient with PCR and/or serology and/or CT-scan confirmed SARS-COV-2 infection or with suggestive COVID-19 syndrome (fever, fatigue, body aches, headache, cough, dyspnea, sudden onset of anosmia or ageusia in the absence of rhinitis or nasal obstruction) without biological or CT-scan confirmation during the period of March 1, 2020 to September 30, 2020.
* Inpatient or outpatient
* Patient informed of the research and, by way of derogation, patient treated in an emergency situation

Exclusion Criteria:

* Patients whose cancer in the cohort was treated curatively more than 5 years ago, with no evidence of recurrence at the time of the SARS-COV-2 infection.
* Patient expressing opposition to participating in the cohort
* Patient subject to a protective measure (patient under guardianship or curatorship)

Primary outcomes:
measure: Number of cases of SARS-COV-2 infection and mortality rate directly related to the infection in patients being followed for digestive, thoracic, head and neck, gynecologic, cerebral, urologic or cutaneous cancer
timeFrame: 3 months
Secondary outcomes:
measure: Number of cases of SARS-COV-2 infection
timeFrame: 3 months
measure: Percentage of severe and fatal forms.of cases of SARS-COV-2 infection
timeFrame: 3 months
measure: Social characteristics of individuals on treatment
timeFrame: 3 months
measure: Link between socio-territorial determinants and the characteristics/severity of SARS-COV-2 infection.
timeFrame: 3 months
Other outcomes:
Locations:
city: Abbeville
country: France
facility: Ch D'Abbeville
city: Amiens
country: France
facility: CHU - Hôpital Sud
city: Angers
country: France
facility: CHU - Hôtel Dieu
city: Antony
country: France
facility: Hôpital Privé
city: Argenteuil
country: France
facility: CH Victor Dupouy
city: Ars-Laquenexy
country: France
facility: CH - Metz Thionville Mercy
city: Auch
country: France
facility: Hôpital Général d'Auch
city: Auxerre
country: France
facility: Ch-Ght Unyon Auxerre
city: Avignon
country: France
facility: CH - Henri Duffaut
city: Avignon
country: France
facility: PRIVE - Sainte Catherine
city: Bayeux
country: France
facility: CH
city: Bayonne
country: France
facility: CH - Côte Basque
city: Beauvais
country: France
facility: CH
city: Besançon
country: France
facility: CHU - Jean Minjoz
city: Besançon
country: France
facility: PRIVE - Franche Comté
city: Beuvry
country: France
facility: PRIVE - Centre Pierre Curie
city: Blois
country: France
facility: CH
city: Bordeaux
country: France
facility: PRIVE - Tivoli
city: Boulogne-sur-Mer
country: France
facility: CH - Duchenne
city: Boulogne
country: France
facility: CHU - Ambroise Paré
city: Bourg-en-Bresse
country: France
facility: CH - Fleyriat
city: Brest
country: France
facility: CHU - Morvan
city: Bron
country: France
facility: CHU - Pierre Wertheimer
city: Béthune
country: France
facility: CH - Germon et Gauthier - Service de Gastroentérologie
city: Béziers
country: France
facility: CH
city: Caen
country: France
facility: CHU - Côte de Nacre
city: Caen
country: France
facility: PRIVE - François Baclesse
city: Calais
country: France
facility: CH
city: Caluire-et-Cuire
country: France
facility: PRIVE - Infirmerie protestante
city: Cannes
country: France
facility: CH
city: Challes-les-Eaux
country: France
facility: PRIVE - Médipole de Savoie
city: Chambray-lès-Tours
country: France
facility: PRIVE - Pôle Santé Léonard de Vinci
city: Charleville-Mézières
country: France
facility: CH
city: Chauny
country: France
facility: CH
city: Cherbourg
country: France
facility: CHP du Cotentin
city: Cholet
country: France
facility: CH
city: Châlons-en-Champagne
country: France
facility: CH
city: Clamart
country: France
facility: CH - HIA Percy
city: Clermont-Ferrand
country: France
facility: CHU - Estaing
city: Clermont-Ferrand
country: France
facility: PRIVE - CAC Jean PERRIN
city: Clichy
country: France
facility: CHU - Beaujon
city: Colmar
country: France
facility: CH - Hôpitaux civils de Colmar
city: Colombes
country: France
facility: CHU - Louis MOURIER
city: Compiègne
country: France
facility: CH - Compiegne
city: Compiègne
country: France
facility: PRIVE - Saint Côme
city: Corbeil-Essonnes
country: France
facility: CH - Sud Francilien
city: Cornebarrieu
country: France
facility: PRIVE - Cédres
city: Coudekerque-Branche
country: France
facility: PRIVE - Clinique de Flandre
city: Creil
country: France
facility: CH - GHPSO Site de Creil
city: Créteil
country: France
facility: Ch - C.H.I.C.
city: Créteil
country: France
facility: CHU - Henri Mondor
city: Dechy
country: France
facility: PRIVE - Centre Léonard de Vinci
city: Dijon
country: France
facility: CHU - Hôpital François Mitterand
city: Dijon
country: France
facility: PRIVE - CAC GF Leclerc
city: Dijon
country: France
facility: PRIVE - Institut de Cancérologie de Bourgogne GRReCC
city: Dole
country: France
facility: CH - Louis Pasteur
city: Douai
country: France
facility: CH
city: Dreux
country: France
facility: CH - Victor Jousselin
city: Ermont
country: France
facility: PRIVE - Clinique Claude Bernard
city: Fréjus
country: France
facility: CH - Frejus Saint Raphael
city: Férolles-Attilly
country: France
facility: PRIVE - Forcilles
city: Grasse
country: France
facility: CH
city: Grenoble
country: France
facility: CHU - Grenoble Alpes
city: Grenoble
country: France
facility: PRIVE - GHM Daniel Hollard
city: Jossigny
country: France
facility: CH - Marne La Vallée/Jossigny
city: La Roche-sur-Yon
country: France
facility: CH - CHD Vendée
city: Le Coudray
country: France
facility: CH - Louis Pasteur
city: Le Havre
country: France
facility: PRIVE - L'Estuaire
city: Le Mans
country: France
facility: PRIVE - Centre Jean Bernard
city: Lens
country: France
facility: CH - Docteur Schaffner
city: Lille
country: France
facility: CH - Saint Vincent
city: Lille
country: France
facility: CHU - Claude Huriez
city: Lille
country: France
facility: PRIVE - CAC Oscar Lambret
city: Lille
country: France
facility: PRIVE - La Louvière Institut de Cancérologie Lille Métropole
city: Lisieux
country: France
facility: CH - Robert Bisson
city: Liévin
country: France
facility: PRIVE - Teissier
city: Longjumeau
country: France
facility: CH - GH Nord Essone
city: Lorient
country: France
facility: CH - CHBS Hôpital du Scrorff
city: Lyon
country: France
facility: CHU - Edouard Herriot
city: Lyon
country: France
facility: CHU - La Croix Rousse
city: Lyon
country: France
facility: PRIVE - La Sauvegarde Lyon
city: Marseille
country: France
facility: CH - La Conception
city: Marseille
country: France
facility: CH - Saint Joseph
city: Marseille
country: France
facility: CHU - La Timone
city: Meaux
country: France
facility: CH - GHI de l'Est Francilien Site de Meaux
city: Mont-de-Marsan
country: France
facility: CH - Layné
city: Montbéliard
country: France
facility: CH - Site du Mittan
city: Montélimar
country: France
facility: CH
city: Mulhouse
country: France
facility: CH - Emile Muller
city: Mâcon
country: France
facility: CH - Les Chanaux
city: Nancy
country: France
facility: PRIVE - Oncologie Gentilly
city: Nantes
country: France
facility: PRIVE - Confluent SAS
city: Neuilly-sur-Seine
country: France
facility: PRIVE - Hartmann
city: Nevers
country: France
facility: CH - Pierre Beregovoy
city: Niort
country: France
facility: CH
city: Nîmes
country: France
facility: CHU - Caremeau
city: Orléans
country: France
facility: CHR - Centre Hospitalier Régional La Source
city: Paris
country: France
facility: AP - HP - Pitié Salpêtrière
city: Paris
country: France
facility: Bichat
city: Paris
country: France
facility: CHU - Cochin
city: Paris
country: France
facility: CHU - Lariboisière
city: Paris
country: France
facility: CHU - Saint Antoine
city: Paris
country: France
facility: CHU - Saint Louis
city: Paris
country: France
facility: CHU - Tenon
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses Croix Saint Simon
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: PRIVE - Saint Joseph
city: Paris
country: France
facility: Privé - Montsouris
city: Perpignan
country: France
facility: PRIVE - Centre Oncologie Catalan
city: Pessac
country: France
facility: CHU - Haut Lévêque
city: Pierre-Bénite
country: France
facility: CHU - Lyon Sud
city: Plérin
country: France
facility: PRIVE - Centre Cario HPCA
city: Poitiers
country: France
facility: CHU - La Miletrie
city: Pontoise
country: France
facility: CH - René Dubos
city: Périgueux
country: France
facility: CH
city: Quint-Fonsegrives
country: France
facility: PRIVE - Clinique La Croix du Sud
city: Reims
country: France
facility: CHU - Robert Debré
city: Reims
country: France
facility: PRIVE - Polyclinique Courlancy
city: Reims
country: France
facility: PRIVEE - Jean Godinot
city: Reims
country: France
facility: PRIVEE - Polyclinique Courlancy
city: Rouen
country: France
facility: CHU - Charles Nicolle
city: Saint-Cloud
country: France
facility: CAC - Institut Curie R. Huguenin
city: Saint-Grégoire
country: France
facility: PRIVE - Saint Grégoire
city: Saint-Malo
country: France
facility: CH - Centre Hospitalier de Saint Malo
city: Saint-Mandé
country: France
facility: CH - Begin
city: Saint-Nazaire
country: France
facility: PRIVE - Clinique Mutualiste de l'Estuaire
city: Saint-Priest-en-Jarez
country: France
facility: CHU - Hôpital Nord CHU Saint Etienne
city: Saint-Étienne
country: France
facility: PRIVE - Ramsay Sainte Loire
city: Sainte-Colombe
country: France
facility: PRIVE - Trenel
city: Strasbourg
country: France
facility: CHU - Hautepierre
city: Strasbourg
country: France
facility: ICAN - Institut de Cancérologie de Strasbourg Europe
city: Strasbourg
country: France
facility: PRIVE - Strasbourg Oncologie Libérale
city: Suresnes
country: France
facility: CH - Foch
city: Talence
country: France
facility: CH - Maison Santé Protestante
city: Tarbes
country: France
facility: CH - Birgorre
city: Thonon-les-Bains
country: France
facility: CH - Leman
city: Toulon
country: France
facility: CH - Sainte Musse
city: Toulouse
country: France
facility: CAC - Oncopole
city: Toulouse
country: France
facility: CHU - Rangueil
city: Tourcoing
country: France
facility: CH - Gustave Dron
city: Tours
country: France
facility: CHU - Bretonneau
city: Valence
country: France
facility: CH
city: Valenciennes
country: France
facility: CH
city: Valenciennes
country: France
facility: PRIVE - Dentellières
city: Vandœuvre-lès-Nancy
country: France
facility: CHU - Brabois
city: Vantoux
country: France
facility: PRIVE - Robert Schuman
city: Vesoul
country: France
facility: CH - Paul Morel
city: Villejuif
country: France
facility: CAC - Gustave Roussy
Study officials:
affiliation: Federation Francophone de Cancerologie Digestive
name: Cécile GIRAULT
role: STUDY_DIRECTOR
References: