The GCO-002 CACOVID-19 Cohort: a French Nationwide Multicenter Study of COVID-19 Infected Cancer Patients

Cancer Clinical Trial

— CACOVID-19  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04397575
• Other study ID #: GCO002 CACOVID-19
• Status: Completed
• Start date: April 3, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: March 2022
• Source: Federation Francophone de Cancerologie Digestive
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1523
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
France	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	CH - Germon et Gauthier - Service de Gastroentérologie	Béthune
France	PRIVE - Centre Pierre Curie	Beuvry
France	CH	Béziers
France	CH	Blois
France	PRIVE - Tivoli	Bordeaux
France	CHU - Ambroise Paré	Boulogne
France	CH - Duchenne	Boulogne-sur-Mer
France	CH - Fleyriat	Bourg-en-Bresse
France	CHU - Morvan	Brest
France	CHU - Pierre Wertheimer	Bron
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	CH	Châlons-en-Champagne
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 - 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	PRIVE - Forcilles	Férolles-Attilly
France	CH - Frejus Saint Raphael	Fréjus
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	PRIVE - Teissier	Liévin
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	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 - Les Chanaux	Mâcon
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	PRIVE - Oncologie Gentilly	Nancy
France	PRIVE - Confluent SAS	Nantes
France	PRIVE - Hartmann	Neuilly-sur-Seine
France	CH - Pierre Beregovoy	Nevers
France	CHU - Caremeau	Nîmes
France	CH	Niort
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	Privé - Montsouris	Paris
France	PRIVE - Saint Joseph	Paris
France	CH	Périgueux
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	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 - Ramsay Sainte Loire	Saint-Étienne
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 - 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

Sponsors (6)

Lead Sponsor	Collaborator
Federation Francophone de Cancerologie Digestive	ARCAGY/ GINECO GROUP, Association de Neuro-Oncologues d'Expression Francaise, GERCOR - Multidisciplinary Oncology Cooperative Group, GORTEC, Intergroupe Francophone de Cancerologie Thoracique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	3 months
Secondary	Number of cases of SARS-COV-2 infection	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 more	3 months
Secondary	Percentage of severe and fatal forms.of cases of SARS-COV-2 infection	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 more	3 months
Secondary	Social characteristics of individuals on treatment	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	3 months
Secondary	Link between socio-territorial determinants and the characteristics/severity of SARS-COV-2 infection.	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.	3 months

External Links

•   Study results