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Spots Global Cancer Trial Database for The GCO-002 CACOVID-19 Cohort: a French Nationwide Multicenter Study of COVID-19 Infected Cancer Patients

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Trial Identification

Brief Title: 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 ID: NCT04397575

Interventions

Study Description

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

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

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

Contact Details

Name: Cécile GIRAULT

Affiliation: Federation Francophone de Cancerologie Digestive

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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