The GCO-002 CACOVID-19 Cohort: a French Nationwide Multicenter Study of COVID-19 Infected Cancer Patients
- Conditions
- CancerImmunotherapySolid TumorSocial InequalityChemotherapySurgeryRadiotherapyCOVIDFrench National Cohort
- Registration Number
- NCT04397575
- Lead Sponsor
- Federation Francophone de Cancerologie Digestive
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1523
- 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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 3 months Describe the number of cases of SARS-COV-2 infection, including those with severe form, and the mortality rate directly related to the infection in patients being followed for any of the following cancers: digestive, thoracic, head and neck, gynecologic, cerebral, urologic, or cutaneous
- Secondary Outcome Measures
Name Time Method Number of cases of SARS-COV-2 infection 3 months Describe the number of cases of SARS-COV-2 infection according to:
* Tumor location
* metastatic or localized status
* status treated or under surveillance
* the type of cancer treatment n the 3 months prior to the occurrence of COVID-19 or moreSocial characteristics of individuals on treatment 3 months Social characteristics of individuals (dwelling place with a INSE code, ) impact on the treatment management of cancer. Information of dwelling place (INSE code), socio-professional leve (INSEE classification) will be collected
Percentage of severe and fatal forms.of cases of SARS-COV-2 infection 3 months Describe the percentage of severe and fatal forms respectively according to :
* Tumor location
* metastatic or localized status
* status treated or under surveillance
* type of cancer treatment received in the 3 months prior to the occurrence of COVID-19 or moreLink between socio-territorial determinants and the characteristics/severity of SARS-COV-2 infection. 3 months Analyze the link between socio-territorial determinants and the characteristics/severity of SARS-COV-2 infection, as well as the impact of the infection on cancer management.
Trial Locations
- Locations (131)
PRIVE - Forcilles
🇫🇷Férolles-Attilly, France
CHU - Grenoble Alpes
🇫🇷Grenoble, France
Groupe Hospitalier Diaconesses Croix Saint Simon
🇫🇷Paris, France
CHU - Haut Lévêque
🇫🇷Pessac, France
CHU - La Miletrie
🇫🇷Poitiers, France
PRIVE - Clinique La Croix du Sud
🇫🇷Quint-Fonsegrives, France
PRIVE - Polyclinique Courlancy
🇫🇷Reims, France
PRIVEE - Jean Godinot
🇫🇷Reims, France
CHU - Hautepierre
🇫🇷Strasbourg, France
ICAN - Institut de Cancérologie de Strasbourg Europe
🇫🇷Strasbourg, France
PRIVE - Strasbourg Oncologie Libérale
🇫🇷Strasbourg, France
CHU - Beaujon
🇫🇷Clichy, France
CH - Compiegne
🇫🇷Compiègne, France
PRIVE - Saint Côme
🇫🇷Compiègne, France
CHU - Hôpital François Mitterand
🇫🇷Dijon, France
CH - René Dubos
🇫🇷Pontoise, France
Hôpital Européen Georges Pompidou
🇫🇷Paris, France
CH - Henri Duffaut
🇫🇷Avignon, France
Ch D'Abbeville
🇫🇷Abbeville, France
CHU - Hôpital Sud
🇫🇷Amiens, France
CHU - Hôtel Dieu
🇫🇷Angers, France
Hôpital Privé
🇫🇷Antony, France
CH - Metz Thionville Mercy
🇫🇷Ars-Laquenexy, France
CH Victor Dupouy
🇫🇷Argenteuil, France
Hôpital Général d'Auch
🇫🇷Auch, France
Ch-Ght Unyon Auxerre
🇫🇷Auxerre, France
PRIVE - Sainte Catherine
🇫🇷Avignon, France
CH - Côte Basque
🇫🇷Bayonne, France
CHU - Jean Minjoz
🇫🇷Besançon, France
CH
🇫🇷Valenciennes, France
PRIVE - Centre Pierre Curie
🇫🇷Beuvry, France
PRIVE - Franche Comté
🇫🇷Besançon, France
PRIVE - Tivoli
🇫🇷Bordeaux, France
CH - Duchenne
🇫🇷Boulogne-sur-Mer, France
CHU - Ambroise Paré
🇫🇷Boulogne, France
CH - Fleyriat
🇫🇷Bourg-en-Bresse, France
CH - Germon et Gauthier - Service de Gastroentérologie
🇫🇷Béthune, France
CHU - Morvan
🇫🇷Brest, France
CHU - Pierre Wertheimer
🇫🇷Bron, France
PRIVE - Médipole de Savoie
🇫🇷Challes-les-Eaux, France
CHU - Estaing
🇫🇷Clermont-Ferrand, France
CHU - Côte de Nacre
🇫🇷Caen, France
PRIVE - François Baclesse
🇫🇷Caen, France
PRIVE - Infirmerie protestante
🇫🇷Caluire-et-Cuire, France
PRIVE - CAC Jean PERRIN
🇫🇷Clermont-Ferrand, France
PRIVE - Pôle Santé Léonard de Vinci
🇫🇷Chambray-lès-Tours, France
CH - HIA Percy
🇫🇷Clamart, France
CHP du Cotentin
🇫🇷Cherbourg, France
CH - Hôpitaux civils de Colmar
🇫🇷Colmar, France
CHU - Louis MOURIER
🇫🇷Colombes, France
CH - Sud Francilien
🇫🇷Corbeil-Essonnes, France
PRIVE - Clinique de Flandre
🇫🇷Coudekerque-Branche, France
PRIVE - Cédres
🇫🇷Cornebarrieu, France
Ch - C.H.I.C.
🇫🇷Créteil, France
CHU - Henri Mondor
🇫🇷Créteil, France
PRIVE - Centre Léonard de Vinci
🇫🇷Dechy, France
CH - GHPSO Site de Creil
🇫🇷Creil, France
PRIVE - CAC GF Leclerc
🇫🇷Dijon, France
PRIVE - Institut de Cancérologie de Bourgogne GRReCC
🇫🇷Dijon, France
PRIVE - Clinique Claude Bernard
🇫🇷Ermont, France
CH - Louis Pasteur
🇫🇷Le Coudray, France
PRIVE - GHM Daniel Hollard
🇫🇷Grenoble, France
CH - Frejus Saint Raphael
🇫🇷Fréjus, France
CH - Victor Jousselin
🇫🇷Dreux, France
CH - CHD Vendée
🇫🇷La Roche-sur-Yon, France
CH - Marne La Vallée/Jossigny
🇫🇷Jossigny, France
PRIVE - L'Estuaire
🇫🇷Le Havre, France
PRIVE - Centre Jean Bernard
🇫🇷Le Mans, France
CH - Docteur Schaffner
🇫🇷Lens, France
CHU - Claude Huriez
🇫🇷Lille, France
CH - Saint Vincent
🇫🇷Lille, France
PRIVE - CAC Oscar Lambret
🇫🇷Lille, France
PRIVE - La Louvière Institut de Cancérologie Lille Métropole
🇫🇷Lille, France
CH - Robert Bisson
🇫🇷Lisieux, France
CH - CHBS Hôpital du Scrorff
🇫🇷Lorient, France
PRIVE - Teissier
🇫🇷Liévin, France
CH - GH Nord Essone
🇫🇷Longjumeau, France
CHU - Edouard Herriot
🇫🇷Lyon, France
PRIVE - La Sauvegarde Lyon
🇫🇷Lyon, France
CHU - La Croix Rousse
🇫🇷Lyon, France
CH - La Conception
🇫🇷Marseille, France
CHU - La Timone
🇫🇷Marseille, France
CH - Saint Joseph
🇫🇷Marseille, France
CH - GHI de l'Est Francilien Site de Meaux
🇫🇷Meaux, France
CH - Site du Mittan
🇫🇷Montbéliard, France
CH - Emile Muller
🇫🇷Mulhouse, France
CH - Layné
🇫🇷Mont-de-Marsan, France
PRIVE - Confluent SAS
🇫🇷Nantes, France
CH - Les Chanaux
🇫🇷Mâcon, France
PRIVE - Oncologie Gentilly
🇫🇷Nancy, France
CHR - Centre Hospitalier Régional La Source
🇫🇷Orléans, France
CHU - Caremeau
🇫🇷Nîmes, France
CH - Pierre Beregovoy
🇫🇷Nevers, France
AP - HP - Pitié Salpêtrière
🇫🇷Paris, France
PRIVE - Hartmann
🇫🇷Neuilly-sur-Seine, France
CHU - Saint Louis
🇫🇷Paris, France
Bichat
🇫🇷Paris, France
CHU - Cochin
🇫🇷Paris, France
CHU - Lariboisière
🇫🇷Paris, France
CHU - Saint Antoine
🇫🇷Paris, France
CHU - Tenon
🇫🇷Paris, France
PRIVE - Saint Joseph
🇫🇷Paris, France
CHU - Lyon Sud
🇫🇷Pierre-Bénite, France
PRIVE - Centre Oncologie Catalan
🇫🇷Perpignan, France
Privé - Montsouris
🇫🇷Paris, France
PRIVE - Centre Cario HPCA
🇫🇷Plérin, France
CHU - Robert Debré
🇫🇷Reims, France
PRIVEE - Polyclinique Courlancy
🇫🇷Reims, France
CAC - Institut Curie R. Huguenin
🇫🇷Saint-Cloud, France
PRIVE - Saint Grégoire
🇫🇷Saint-Grégoire, France
CHU - Charles Nicolle
🇫🇷Rouen, France
PRIVE - Clinique Mutualiste de l'Estuaire
🇫🇷Saint-Nazaire, France
CH - Centre Hospitalier de Saint Malo
🇫🇷Saint-Malo, France
CH - Begin
🇫🇷Saint-Mandé, France
CHU - Hôpital Nord CHU Saint Etienne
🇫🇷Saint-Priest-en-Jarez, France
PRIVE - Ramsay Sainte Loire
🇫🇷Saint-Étienne, France
PRIVE - Trenel
🇫🇷Sainte-Colombe, 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
CH - Gustave Dron
🇫🇷Tourcoing, France
CAC - Oncopole
🇫🇷Toulouse, France
CHU - Rangueil
🇫🇷Toulouse, France
CHU - Bretonneau
🇫🇷Tours, 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