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CancerOnCovidNCT04393974

COVID-19 and Cancer Patients

An observational study of Cancer and Sars-CoV2, run by Imperial College London at 25 sites in 6 countries.

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

Routinely collected data will be used to assess the morbidity and mortality of cancer patients following a positive COVID-19 infection. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Sars-CoV2
How many people
3,820 participants
Where
25 sitesin 6 countries
Study dates
1 Apr 2020to 1 Apr 2024
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
  • Adult, Older adult

Study population: All patients 18 years old or above with cancer and who have also tested positive for Sars-Cov2.

Who may be able to join

  • The investigators will evaluate and include consecutive patients observed in the outpatients and inpatients facility of the study centre meeting all the following CRITERIA:
  • Be ≥18 years of age.
  • Have a confirmed diagnosis of malignancy of any type.
  • Have a confirmed diagnosis of SARS-CoV-2 infection.

Who cannot join

  • Patients will not be entered in the study database when one or more of the following CRITERIA are present:
  • Unconfirmed diagnosis of SARS-CoV-2 infection
  • Insufficient clinical/follow up data.

Trial locations and contacts

25 sites in 6 countries.

25 sites in 6 countries

Italy10 sites
  • Azienda Ospedaliero Universitaria SS. Antonio e Biagio e Cesare Arrigo

    Alessandria

  • ASST Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia

  • Fondazione Poliambulanza Istituto Ospedaliero

    Brescia

  • Azienda Istituti Ospitalieri di Cremona

    Cremona

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan

  • Humanitas Research Hospital

    Milan

  • Azienda Ospedaliero Universitaria Maggiore della Carità di Novara

    Novara

  • Fondazione IRCCS Policlinico San Matteo

    Pavia

  • Policlinico Universitario Campus Bio-Medico

    Rome

Other trials in Italy

United Kingdom7 sites
  • Velindre Cancer Centre, Velindre University NHS Trust

    Cardiff, CF14 2TL

  • St Bartholomew's Hopsital, Barts Health NHS Trust

    London, EC1A 7BE

  • University College Hospital, University College London Hospitals NHS Foundation Trust

    London, NW1 2BU

  • Guy's & St Thomas' NHS Foundation Trust

    London, SE1 9RT

  • Chelsea & Westminster Hospital, Chelsea & Westminster Hopsital NHS Foundation Trust

    London, SW10 9NH

  • Imperial College Healthcare NHS Trust

    London, W12 0HS

  • Northumbria Healthcare NHS Foundation Trust

    Newcastle, NE27 0QJ

Other trials in United Kingdom

Spain5 sites
  • Institut Català d'Oncologia Badalona

    Badalona

  • Hospital Clínic de Barcelona

    Barcelona

  • Hospital Universitari de Bellvitge

    Barcelona

  • Hospital Universitari Vall d'Hebron

    Barcelona

  • Institut Català d'Oncologia Hospital Josep Trueta

    Girona

Other trials in Spain

Belgium1 site
  • Institut Jules Bordet

    Brussels

Other trials in Belgium

France1 site
  • Institut Gustave Roussy

    Villejuif

Other trials in France

Germany1 site
  • Ludwig-Maximilians-Universität München

    Munich

Other trials in Germany

About this study

Official title: OnCovid: Natural History and Outcomes of Cancer Patients During the COVID19 Epidemic

Routinely collected data will be used to assess the morbidity and mortality of cancer patients following a positive COVID-19 infection.

Read the detailed description

The SARS-CoV-2, (COVID-19) virus of the coronavirus family is believed to have been transmitted from animal to human. On 12th March 2020, the World Health Organisation (WHO) declared this particular coronavirus outbreak a pandemic.

How COVID-19 affects people is still not widely understood. Some people who have tested positive for the virus have been asymptomatic while others, who were otherwise well and healthy before infection, have died. Currently, information obtained so far suggests that most COVID-19 illness, however older people and people with severe comorbidities such as heart and lung disease and diabetes, seem to be at higher risk of developing serious COVID-19 illness.

This research is a retrospective, non-interventional study whose aim is to describe the features of COVID-19 infection specifically in cancer patients; to investigate its severity in this particular population and evaluate the long-term outcomes by means of medical charts review of consecutive patients co-diagnosed with SARS-CoV-2 infection and malignancy.

Patients will be identified from electronic medical records and entered into a pre-designed database. All information used will have been previously collected as part of routine standard of care and will involve but is not limited to: blood test results, prior and current anti-cancer therapy, medical history and most importantly clinical outcomes, such as response to any treatment provided for COVID-19 and patients' survival in relation to baseline clinic-pathologic profile. All data will be collected by each patient's team and will be anonymised and stored in a password-protected NHS computer.

Conditions
Cancer, Sars-CoV2
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04393974
Study groupRoleWhat they receive
Cancer patients with COVID-19All cancer patients can be recruited onto this research following a positive test for Sars-Cov2. The research will follow what treatments they are given for the infection, but also look at their past medical history including prior and any current anti-cancer therapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Describe presenting characteristics and severity or SARS-CoV-2 infection in patients with cancer

    Compiling a list of symptoms experienced by patients recruited onto the trial

    Measured: 2 years

  2. Assessing what factors are involved in prognosis of cancer patients with COVID-19

    Evaluate prognostic factors for survival in patients with SARS-CoV-2 infection and cancer

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2020
  2. Study start1 Apr 2020
  3. Primary completion1 Apr 2024
  4. Study completion1 Apr 2024

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
Case only
Time perspective
Retrospective
Enrolment
3,820 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04393974
Sponsor's protocol ID
282140
Acronym
OnCovid
Status last verified
Feb 2026
First submitted
18 May 2020
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Cortellini A, Tabernero J, Mukherjee U, Salazar R, Sureda A, Maluquer C, Ferrante D, Bower M, Sharkey R, Mirallas O, Plaja A, Cucurull M, Mesia R, Dalla Pria A, Newsom-Davis T, Van Hemelrijck M, Sita-Lumsden A, Apthorp E, Vincenzi B, Di Fazio GR, Tonini G, Pantano F, Bertuzzi A, Rossi S, Brunet J, Lambertini M, Pedrazzoli P, Biello F, D'Avanzo F, Lee AJX, Shawe-Taylor M, Rogers L, Murphy C, Cooper L, Andaleeb R, Khalique S, Bawany S, Ahmed S, Carmona-Garcia MC, Fort-Culillas R, Linan R, Zoratto F, Rizzo G, Perachino M, Doonga K, Gaidano G, Bruna R, Patriarca A, Martinez-Vila C, Perez Criado I, Giusti R, Mazzoni F, Antonuzzo L, Santoro A, Parisi A, Queirolo P, Aujayeb A, Rimassa L, Diamantis N, Bertulli R, Fulgenzi CAM, D'Alessio A, Ruiz-Camps I, Saoudi-Gonzalez N, Garcia Illescas D, Medina I, Fox L, Gennari A, Aguilar-Company J, Pinato DJ; OnCovid study group. SARS-CoV-2 omicron (B.1.1.529)-related COVID-19 sequelae in vaccinated and unvaccinated patients with cancer: results from the OnCovid registry. Lancet Oncol. 2023 Apr;24(4):335-346. doi: 10.1016/S1470-2045(23)00056-6. Epub 2023 Mar 7.

    PubMed 36898391
  • Tagliamento M, Gennari A, Lambertini M, Salazar R, Harbeck N, Del Mastro L, Aguilar-Company J, Bower M, Sharkey R, Dalla Pria A, Plaja A, Jackson A, Handford J, Sita-Lumsden A, Martinez-Vila C, Matas M, Miguel Rodriguez A, Vincenzi B, Tonini G, Bertuzzi A, Brunet J, Pedrazzoli P, D'Avanzo F, Biello F, Sinclair A, Lee AJX, Rossi S, Rizzo G, Mirallas O, Pimentel I, Iglesias M, Sanchez de Torre A, Guida A, Berardi R, Zambelli A, Tondini C, Filetti M, Mazzoni F, Mukherjee U, Diamantis N, Parisi A, Aujayeb A, Prat A, Libertini M, Grisanti S, Rossi M, Zoratto F, Generali D, Saura C, Lyman GH, Kuderer NM, Pinato DJ, Cortellini A. Pandemic Phase-Adjusted Analysis of COVID-19 Outcomes Reveals Reduced Intrinsic Vulnerability and Substantial Vaccine Protection From Severe Acute Respiratory Syndrome Coronavirus 2 in Patients With Breast Cancer. J Clin Oncol. 2023 May 20;41(15):2800-2814. doi: 10.1200/JCO.22.01667. Epub 2023 Jan 31.

    PubMed 36720089
  • Cortellini A, Dettorre GM, Dafni U, Aguilar-Company J, Castelo-Branco L, Lambertini M, Gennatas S, Angelis V, Sita-Lumsden A, Rogado J, Pedrazzoli P, Vinal D, Prat A, Rossi M, Berardi R, Alonso-Gordoa T, Grisanti S, Dimopoulou G, Queirolo P, Pradervand S, Bertuzzi A, Bower M, Arnold D, Salazar R, Tucci M, Harrington KJ, Mazzoni F, Mukherjee U, Tsourti Z, Michielin O, Pommeret F, Brunet J, Vincenzi B, Tonini G, Patriarca A, Biello F, Krengli M, Tabernero J, Pentheroudakis G, Gennari A, Peters S, Romano E, Pinato DJ. Immune checkpoint inhibitor therapy and outcomes from SARS-CoV-2 infection in patients with cancer: a joint analysis of OnCovid and ESMO-CoCARE registries. J Immunother Cancer. 2022 Nov;10(11):e005732. doi: 10.1136/jitc-2022-005732.

    PubMed 36450384
  • Pinato DJ, Ferrante D, Aguilar-Company J, Bower M, Salazar R, Mirallas O, Sureda A, Bertuzzi A, Brunet J, Lambertini M, Maluquer C, Pedrazzoli P, Biello F, Lee AJX, Sng CCT, Linan R, Rossi S, Carmona-Garcia MC, Sharkey R, Eremiev S, Rizzo G, Bain HD, Yu T, Cruz CA, Perachino M, Saoudi-Gonzalez N, Fort-Culillas R, Doonga K, Fox L, Roldan E, Zoratto F, Gaidano G, Ruiz-Camps I, Bruna R, Patriarca A, Shawe-Taylor M, Fusco V, Martinez-Vila C, Berardi R, Filetti M, Mazzoni F, Santoro A, Delfanti S, Parisi A, Queirolo P, Aujayeb A, Rimassa L, Prat A, Tabernero J, Gennari A, Cortellini A; OnCovid study group. Vaccination against SARS-CoV-2 protects from morbidity, mortality and sequelae from COVID19 in patients with cancer. Eur J Cancer. 2022 Aug;171:64-74. doi: 10.1016/j.ejca.2022.04.036. Epub 2022 May 23.

    PubMed 35704976
  • Pinato DJ, Aguilar-Company J, Ferrante D, Hanbury G, Bower M, Salazar R, Mirallas O, Sureda A, Plaja A, Cucurull M, Mesia R, Townsend S, Jackson A, Dalla Pria A, Newsom-Davis T, Handford J, Sita-Lumsden A, Apthorp E, Vincenzi B, Bertuzzi A, Brunet J, Lambertini M, Maluquer C, Pedrazzoli P, Biello F, Sinclair A, Bawany S, Khalique S, Rossi S, Rogers L, Murphy C, Belessiotis K, Carmona-Garcia MC, Sharkey R, Garcia-Illescas D, Rizzo G, Perachino M, Saoudi-Gonzalez N, Doonga K, Fox L, Roldan E, Gaidano G, Ruiz-Camps I, Bruna R, Patriarca A, Martinez-Vila C, Cantini L, Zambelli A, Giusti R, Mazzoni F, Caliman E, Santoro A, Grosso F, Parisi A, Queirolo P, Aujayeb A, Rimassa L, Prat A, Tucci M, Libertini M, Grisanti S, Mukherjee U, Diamantis N, Fusco V, Generali D, Provenzano S, Gennari A, Tabernero J, Cortellini A; OnCovid study group. Outcomes of the SARS-CoV-2 omicron (B.1.1.529) variant outbreak among vaccinated and unvaccinated patients with cancer in Europe: results from the retrospective, multicentre, OnCovid registry study. Lancet Oncol. 2022 Jul;23(7):865-875. doi: 10.1016/S1470-2045(22)00273-X. Epub 2022 Jun 2.

    PubMed 35660139
  • Pinato DJ, Tabernero J, Bower M, Scotti L, Patel M, Colomba E, Dolly S, Loizidou A, Chester J, Mukherjee U, Zambelli A, Dalla Pria A, Aguilar-Company J, Ottaviani D, Chowdhury A, Merry E, Salazar R, Bertuzzi A, Brunet J, Lambertini M, Tagliamento M, Pous A, Sita-Lumsden A, Srikandarajah K, Colomba J, Pommeret F, Segui E, Generali D, Grisanti S, Pedrazzoli P, Rizzo G, Libertini M, Moss C, Evans JS, Russell B, Harbeck N, Vincenzi B, Biello F, Bertulli R, Linan R, Rossi S, Carmona-Garcia MC, Tondini C, Fox L, Baggi A, Fotia V, Parisi A, Porzio G, Saponara M, Cruz CA, Garcia-Illescas D, Felip E, Roque Lloveras A, Sharkey R, Roldan E, Reyes R, Earnshaw I, Ferrante D, Marco-Hernandez J, Ruiz-Camps I, Gaidano G, Patriarca A, Bruna R, Sureda A, Martinez-Vila C, Sanchez de Torre A, Cantini L, Filetti M, Rimassa L, Chiudinelli L, Franchi M, Krengli M, Santoro A, Prat A, Van Hemelrijck M, Diamantis N, Newsom-Davis T, Gennari A, Cortellini A; OnCovid study group. Prevalence and impact of COVID-19 sequelae on treatment and survival of patients with cancer who recovered from SARS-CoV-2 infection: evidence from the OnCovid retrospective, multicentre registry study. Lancet Oncol. 2021 Dec;22(12):1669-1680. doi: 10.1016/S1470-2045(21)00573-8. Epub 2021 Nov 3.

    PubMed 34741822

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer and Sars-CoV2, run by Imperial College London at 25 sites in 6 countries.

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 4 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 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Italy, United Kingdom, Spain, Belgium, France and 1 more country. 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?

Describe presenting characteristics and severity or SARS-CoV-2 infection in patients with cancer (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04393974, which also lists 6 linked publications.

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 17 Feb 2026.

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