The GCO-002 CACOVID-19 Cohort: a French Nationwide Multicenter Study of COVID-19 Infected Cancer Patients
CACOVID-19
Cohorte Non Interventionnelle Ambispective Nationale Multicentrique de Patients Suivis Pour Cancer et infectés Par le SARS-CoV-2
1 other identifier
observational
1,523
1 country
148
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
148 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 3, 2020
CompletedFirst Submitted
Initial submission to the registry
May 13, 2020
CompletedFirst Posted
Study publicly available on registry
May 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedApril 4, 2022
March 1, 2022
1.5 years
May 13, 2020
March 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Number of cases of SARS-COV-2 infection
3 months
Percentage of severe and fatal forms.of cases of SARS-COV-2 infection
3 months
Social characteristics of individuals on treatment
3 months
Link between socio-territorial determinants and the characteristics/severity of SARS-COV-2 infection.
3 months
Eligibility Criteria
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)
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Federation Francophone de Cancerologie Digestivelead
- ARCAGY/ GINECO GROUPcollaborator
- GERCOR - Multidisciplinary Oncology Cooperative Groupcollaborator
- GORTECcollaborator
- Intergroupe Francophone de Cancerologie Thoraciquecollaborator
- Association de Neuro-Oncologues d'Expression Francaisecollaborator
Study Sites (148)
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 - Germon et Gauthier - Service de Gastroentérologie
Béthune, 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
PRIVE - Pôle Santé Léonard de Vinci
Chambray-lès-Tours, France
CH
Charleville-Mézières, France
CH
Chauny, France
CH
Châlons-en-Champagne, France
CHP du Cotentin
Cherbourg, 50100, 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 - La Conception
Marseille, France
CH - Saint Joseph
Marseille, France
CHU - La Timone
Marseille, France
CH - Les Chanaux
Mâcon, 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
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
CH
Périgueux, 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, 51092, 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-Etienne, France
PRIVE - Saint Grégoire
Saint-Grégoire, 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
CH - Centre Hospitalier de Saint Malo
St-Malo, 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
Related Links
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Cécile GIRAULT
Federation Francophone de Cancerologie Digestive
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2020
First Posted
May 21, 2020
Study Start
April 3, 2020
Primary Completion
September 30, 2021
Study Completion
September 30, 2021
Last Updated
April 4, 2022
Record last verified: 2022-03