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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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

Other trials in France

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.

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.

  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

    Measured: 3 months

Secondary outcomes (4)
  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted21 May 2020
  2. Study start3 Apr 2020
  3. Primary completion30 Sep 2021
  4. Study completion30 Sep 2021

Resources

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
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

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.

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