Official Title
Cohorte Non Interventionnelle Ambispective Nationale Multicentrique de Patients Suivis Pour Cancer et infectés Par le SARS-CoV-2
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.

Completed
Cancer
COVID
Solid Tumor
Social Inequality
French National Cohort
Chemotherapy
Immunotherapy
Surgery
Radiotherapy
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)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
France
Locations

Ch D'Abbeville
Abbeville, France

CHU - Hôpital Sud
Amiens, France

CHU - Hôtel Dieu
Angers, France

Hôpital Privé
Antony, France

CH Victor Dupouy
Argenteuil, France

CH - Metz Thionville Mercy
Ars-Laquenexy, France

Hôpital Général d'Auch
Auch, France

Ch-Ght Unyon Auxerre
Auxerre, France

CH - Henri Duffaut
Avignon, France

PRIVE - Sainte Catherine
Avignon, France

CH
Bayeux, France

CH - Côte Basque
Bayonne, France

CH
Beauvais, France

CHU - Jean Minjoz
Besançon, France

PRIVE - Franche Comté
Besançon, France

PRIVE - Centre Pierre Curie
Beuvry, France

CH
Blois, France

PRIVE - Tivoli
Bordeaux, France

CH - Duchenne
Boulogne-sur-Mer, France

CHU - Ambroise Paré
Boulogne, France

CH - Fleyriat
Bourg-en-Bresse, France

CHU - Morvan
Brest, France

CHU - Pierre Wertheimer
Bron, France

CH - Germon et Gauthier - Service de Gastroentérologie
Béthune, France

CH
Béziers, France

CHU - Côte de Nacre
Caen, France

PRIVE - François Baclesse
Caen, France

CH
Calais, France

PRIVE - Infirmerie protestante
Caluire-et-Cuire, France

CH
Cannes, France

PRIVE - Médipole de Savoie
Challes-les-Eaux, France

PRIVE - Pôle Santé Léonard de Vinci
Chambray-lès-Tours, France

CH
Charleville-Mézières, France

CH
Chauny, France

CHP du Cotentin
Cherbourg, France

CH
Cholet, France

CH
Châlons-en-Champagne, France

CH - HIA Percy
Clamart, France

CHU - Estaing
Clermont-Ferrand, France

PRIVE - CAC Jean PERRIN
Clermont-Ferrand, France

CHU - Beaujon
Clichy, France

CH - Hôpitaux civils de Colmar
Colmar, France

CHU - Louis MOURIER
Colombes, France

CH - Compiegne
Compiègne, France

PRIVE - Saint Côme
Compiègne, France

CH - Sud Francilien
Corbeil-Essonnes, France

PRIVE - Cédres
Cornebarrieu, France

PRIVE - Clinique de Flandre
Coudekerque-Branche, France

CH - GHPSO Site de Creil
Creil, France

Ch - C.H.I.C.
Créteil, France

CHU - Henri Mondor
Créteil, France

PRIVE - Centre Léonard de Vinci
Dechy, France

CHU - Hôpital François Mitterand
Dijon, France

PRIVE - CAC GF Leclerc
Dijon, France

PRIVE - Institut de Cancérologie de Bourgogne GRReCC
Dijon, France

CH - Louis Pasteur
Dole, France

CH
Douai, France

CH - Victor Jousselin
Dreux, France

PRIVE - Clinique Claude Bernard
Ermont, France

CH - Frejus Saint Raphael
Fréjus, France

PRIVE - Forcilles
Férolles-Attilly, France

CH
Grasse, France

CHU - Grenoble Alpes
Grenoble, France

PRIVE - GHM Daniel Hollard
Grenoble, France

CH - Marne La Vallée/Jossigny
Jossigny, France

CH - CHD Vendée
La Roche-sur-Yon, France

CH - Louis Pasteur
Le Coudray, France

PRIVE - L'Estuaire
Le Havre, France

PRIVE - Centre Jean Bernard
Le Mans, France

CH - Docteur Schaffner
Lens, France

CH - Saint Vincent
Lille, France

CHU - Claude Huriez
Lille, France

PRIVE - CAC Oscar Lambret
Lille, France

PRIVE - La Louvière Institut de Cancérologie Lille Métropole
Lille, France

CH - Robert Bisson
Lisieux, France

PRIVE - Teissier
Liévin, France

CH - GH Nord Essone
Longjumeau, France

CH - CHBS Hôpital du Scrorff
Lorient, France

CHU - Edouard Herriot
Lyon, France

CHU - La Croix Rousse
Lyon, France

PRIVE - La Sauvegarde Lyon
Lyon, France

CH - La Conception
Marseille, France

CH - Saint Joseph
Marseille, France

CHU - La Timone
Marseille, France

CH - GHI de l'Est Francilien Site de Meaux
Meaux, France

CH - Layné
Mont-de-Marsan, France

CH - Site du Mittan
Montbéliard, France

CH
Montélimar, France

CH - Emile Muller
Mulhouse, France

CH - Les Chanaux
Mâcon, France

PRIVE - Oncologie Gentilly
Nancy, France

PRIVE - Confluent SAS
Nantes, France

PRIVE - Hartmann
Neuilly-sur-Seine, France

CH - Pierre Beregovoy
Nevers, France

CH
Niort, France

CHU - Caremeau
Nîmes, France

CHR - Centre Hospitalier Régional La Source
Orléans, France

AP - HP - Pitié Salpêtrière
Paris, France

Bichat
Paris, France

CHU - Cochin
Paris, France

CHU - Lariboisière
Paris, France

CHU - Saint Antoine
Paris, France

CHU - Saint Louis
Paris, France

CHU - Tenon
Paris, France

Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, France

Hôpital Européen Georges Pompidou
Paris, France

PRIVE - Saint Joseph
Paris, France

Privé - Montsouris
Paris, France

PRIVE - Centre Oncologie Catalan
Perpignan, France

CHU - Haut Lévêque
Pessac, France

CHU - Lyon Sud
Pierre-Bénite, France

PRIVE - Centre Cario HPCA
Plérin, France

CHU - La Miletrie
Poitiers, France

CH - René Dubos
Pontoise, France

CH
Périgueux, France

PRIVE - Clinique La Croix du Sud
Quint-Fonsegrives, France

CHU - Robert Debré
Reims, France

PRIVE - Polyclinique Courlancy
Reims, France

PRIVEE - Jean Godinot
Reims, France

PRIVEE - Polyclinique Courlancy
Reims, France

CHU - Charles Nicolle
Rouen, France

CAC - Institut Curie R. Huguenin
Saint-Cloud, France

PRIVE - Saint Grégoire
Saint-Grégoire, France

CH - Centre Hospitalier de Saint Malo
Saint-Malo, France

CH - Begin
Saint-Mandé, France

PRIVE - Clinique Mutualiste de l'Estuaire
Saint-Nazaire, France

CHU - Hôpital Nord CHU Saint Etienne
Saint-Priest-en-Jarez, France

PRIVE - Ramsay Sainte Loire
Saint-Étienne, France

PRIVE - Trenel
Sainte-Colombe, France

CHU - Hautepierre
Strasbourg, France

ICAN - Institut de Cancérologie de Strasbourg Europe
Strasbourg, France

PRIVE - Strasbourg Oncologie Libérale
Strasbourg, France

CH - Foch
Suresnes, France

CH - Maison Santé Protestante
Talence, France

CH - Birgorre
Tarbes, France

CH - Leman
Thonon-les-Bains, France

CH - Sainte Musse
Toulon, France

CAC - Oncopole
Toulouse, France

CHU - Rangueil
Toulouse, France

CH - Gustave Dron
Tourcoing, France

CHU - Bretonneau
Tours, France

CH
Valence, France

CH
Valenciennes, France

PRIVE - Dentellières
Valenciennes, France

CHU - Brabois
Vandœuvre-lès-Nancy, France

PRIVE - Robert Schuman
Vantoux, France

CH - Paul Morel
Vesoul, France

CAC - Gustave Roussy
Villejuif, France

Cécile GIRAULT, Study Director
Federation Francophone de Cancerologie Digestive

Federation Francophone de Cancerologie Digestive
NCT Number
Keywords
cancer
Covid
Solid tumor
social inequality
french national cohort
Chemotherapy
Immunotherapy
Surgery
RADIOTHERAPY