CancerCACOVID-19NCT04397575
The GCO-002 CACOVID-19 Cohort: a French Nationwide Multicenter Study of COVID-19 Infected Cancer Patients
An observational study of Cancer and COVID, run by Federation Francophone de Cancerologie Digestive at 148 sites in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, COVID, Solid Tumor
- How many people
- 1,523 participants
- Where
- 148 sitesFrance
- Study dates
- 3 Apr 2020to 30 Sep 2021
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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)
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
148 sites in 1 country.
148 sites in 1 country
France148 sites
Ch D'Abbeville
Abbeville
CHU - Hôpital Sud
Amiens
CHU - Hôtel Dieu
Angers
Hôpital Privé
Antony
CH Victor Dupouy
Argenteuil
CH - Metz Thionville Mercy
Ars-Laquenexy
Hôpital Général d'Auch
Auch
Ch-Ght Unyon Auxerre
Auxerre
CH - Henri Duffaut
Avignon
PRIVE - Sainte Catherine
Avignon
CH
Bayeux
CH - Côte Basque
Bayonne
CH
Beauvais
CHU - Jean Minjoz
Besançon
PRIVE - Franche Comté
Besançon
CH - Germon et Gauthier - Service de Gastroentérologie
Béthune
PRIVE - Centre Pierre Curie
Beuvry
CH
Béziers
CH
Blois
PRIVE - Tivoli
Bordeaux
CHU - Ambroise Paré
Boulogne
CH - Duchenne
Boulogne-sur-Mer
CH - Fleyriat
Bourg-en-Bresse
CHU - Morvan
Brest
CHU - Pierre Wertheimer
Bron
CHU - Côte de Nacre
Caen
PRIVE - François Baclesse
Caen
CH
Calais
PRIVE - Infirmerie protestante
Caluire-et-Cuire
CH
Cannes
PRIVE - Médipole de Savoie
Challes-les-Eaux
CH
Châlons-en-Champagne
PRIVE - Pôle Santé Léonard de Vinci
Chambray-lès-Tours
CH
Charleville-Mézières
CH
Chauny
CHP du Cotentin
Cherbourg, 50100
CH
Cholet
CH - HIA Percy
Clamart
CHU - Estaing
Clermont-Ferrand
PRIVE - CAC Jean PERRIN
Clermont-Ferrand
CHU - Beaujon
Clichy
CH - Hôpitaux civils de Colmar
Colmar
CHU - Louis MOURIER
Colombes
CH - Compiegne
Compiègne
PRIVE - Saint Côme
Compiègne
CH - Sud Francilien
Corbeil-Essonnes
PRIVE - Cédres
Cornebarrieu
PRIVE - Clinique de Flandre
Coudekerque-Branche
CH - GHPSO Site de Creil
Creil
Ch - C.H.I.C.
Créteil
CHU - Henri Mondor
Créteil
PRIVE - Centre Léonard de Vinci
Dechy
CHU - Hôpital François Mitterand
Dijon
PRIVE - CAC GF Leclerc
Dijon
PRIVE - Institut de Cancérologie de Bourgogne GRReCC
Dijon
CH - Louis Pasteur
Dole
CH
Douai
CH - Victor Jousselin
Dreux
PRIVE - Clinique Claude Bernard
Ermont
PRIVE - Forcilles
Férolles-Attilly
CH - Frejus Saint Raphael
Fréjus
CH
Grasse
CHU - Grenoble Alpes
Grenoble
PRIVE - GHM Daniel Hollard
Grenoble
CH - Marne La Vallée/Jossigny
Jossigny
CH - CHD Vendée
La Roche-sur-Yon
CH - Louis Pasteur
Le Coudray
PRIVE - L'Estuaire
Le Havre
PRIVE - Centre Jean Bernard
Le Mans
CH - Docteur Schaffner
Lens
PRIVE - Teissier
Liévin
CH - Saint Vincent
Lille
CHU - Claude Huriez
Lille
PRIVE - CAC Oscar Lambret
Lille
PRIVE - La Louvière Institut de Cancérologie Lille Métropole
Lille
CH - Robert Bisson
Lisieux
CH - GH Nord Essone
Longjumeau
CH - CHBS Hôpital du Scrorff
Lorient
CHU - Edouard Herriot
Lyon
CHU - La Croix Rousse
Lyon
PRIVE - La Sauvegarde Lyon
Lyon
CH - Les Chanaux
Mâcon
CH - La Conception
Marseille
CH - Saint Joseph
Marseille
CHU - La Timone
Marseille
CH - GHI de l'Est Francilien Site de Meaux
Meaux
CH - Layné
Mont-de-Marsan
CH - Site du Mittan
Montbéliard
CH
Montélimar
CH - Emile Muller
Mulhouse
PRIVE - Oncologie Gentilly
Nancy
PRIVE - Confluent SAS
Nantes
PRIVE - Hartmann
Neuilly-sur-Seine
CH - Pierre Beregovoy
Nevers
CHU - Caremeau
Nîmes
CH
Niort
CHR - Centre Hospitalier Régional La Source
Orléans
AP - HP - Pitié Salpêtrière
Paris
Bichat
Paris
CHU - Cochin
Paris
CHU - Lariboisière
Paris
CHU - Saint Antoine
Paris
CHU - Saint Louis
Paris
CHU - Tenon
Paris
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris
Hôpital Européen Georges Pompidou
Paris
PRIVE - Saint Joseph
Paris
Privé - Montsouris
Paris
CH
Périgueux
PRIVE - Centre Oncologie Catalan
Perpignan
CHU - Haut Lévêque
Pessac
CHU - Lyon Sud
Pierre-Bénite
PRIVE - Centre Cario HPCA
Plérin
CHU - La Miletrie
Poitiers
CH - René Dubos
Pontoise
PRIVE - Clinique La Croix du Sud
Quint-Fonsegrives
CHU - Robert Debré
Reims, 51092
PRIVE - Polyclinique Courlancy
Reims
PRIVEE - Jean Godinot
Reims
PRIVEE - Polyclinique Courlancy
Reims
CHU - Charles Nicolle
Rouen
CAC - Institut Curie R. Huguenin
Saint-Cloud
PRIVE - Ramsay Sainte Loire
Saint-Etienne
PRIVE - Saint Grégoire
Saint-Grégoire
CH - Begin
Saint-Mandé
PRIVE - Clinique Mutualiste de l'Estuaire
Saint-Nazaire
CHU - Hôpital Nord CHU Saint Etienne
Saint-Priest-en-Jarez
PRIVE - Trenel
Sainte-Colombe
CH - Centre Hospitalier de Saint Malo
St-Malo
CHU - Hautepierre
Strasbourg
ICAN - Institut de Cancérologie de Strasbourg Europe
Strasbourg
PRIVE - Strasbourg Oncologie Libérale
Strasbourg
CH - Foch
Suresnes
CH - Maison Santé Protestante
Talence
CH - Birgorre
Tarbes
CH - Leman
Thonon-les-Bains
CH - Sainte Musse
Toulon
CAC - Oncopole
Toulouse
CHU - Rangueil
Toulouse
CH - Gustave Dron
Tourcoing
CHU - Bretonneau
Tours
CH
Valence
CH
Valenciennes
PRIVE - Dentellières
Valenciennes
CHU - Brabois
Vandœuvre-lès-Nancy
PRIVE - Robert Schuman
Vantoux
CH - Paul Morel
Vesoul
CAC - Gustave Roussy
Villejuif
About this study
Official title: Cohorte Non Interventionnelle Ambispective Nationale Multicentrique de Patients Suivis Pour Cancer et infectés Par le SARS-CoV-2
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.
Read more
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.
Read the 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.
- Conditions
- Cancer, COVID, Solid Tumor, Social Inequality, French National Cohort, Chemotherapy
- Keywords
- cancer, COVID, solid tumor, social inequality, french national cohort, chemotherapy, Immunotherapy, surgery, radiotherapy
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (4)
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
Measured: 3 months
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
Measured: 3 months
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
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start3 Apr 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,523 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Federation Francophone de Cancerologie Digestive
- Sponsor type
- University, hospital or other
- Collaborators
- ARCAGY/ GINECO GROUP, GERCOR - Multidisciplinary Oncology Cooperative Group, GORTEC, Intergroupe Francophone de Cancerologie Thoracique, Association de Neuro-Oncologues d'Expression Francaise
- Responsible party
- Sponsor
- Investigators
- Cécile GIRAULT, Study director, Federation Francophone de Cancerologie Digestive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397575
- Sponsor's protocol ID
- GCO002 CACOVID-19
- Acronym
- CACOVID-19
- Status last verified
- Mar 2022
- First submitted
- 13 May 2020
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohorte Non Interventionnelle Ambispective Nationale Multicentrique de Patients Suivis Pour Cancer et infectés Par le SARS-CoV-2
- ClinicalTrials.gov ID
- NCT04397575
- Acronym / sponsor ID
- CACOVID-19 / GCO002 CACOVID-19
- Conditions
- Cancer, COVID, Solid Tumor, Social Inequality, French National Cohort, Chemotherapy
- Keywords
- cancer, COVID, solid tumor, social inequality, french national cohort, chemotherapy, Immunotherapy, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,523 participants (actual)
- Lead sponsor
- Federation Francophone de Cancerologie DigestiveUniversity, hospital or other
- Collaborators
- ARCAGY/ GINECO GROUP, GERCOR - Multidisciplinary Oncology Cooperative Group, GORTEC, Intergroupe Francophone de Cancerologie Thoracique, Association de Neuro-Oncologues d'Expression Francaise
- Study start
- 3 Apr 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 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
4 secondary outcomes
Number of cases of SARS-COV-2 infection
Time frame: 3 months
Percentage of severe and fatal forms.of cases of SARS-COV-2 infection
Time frame: 3 months
Social characteristics of individuals on treatment
Time frame: 3 months
Link between socio-territorial determinants and the characteristics/severity of SARS-COV-2 infection.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Study resultsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cécile GIRAULT study director
Federation Francophone de Cancerologie Digestive
148 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and COVID, run by Federation Francophone de Cancerologie Digestive at 148 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 148 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.