COVID-19 and Cancer Patients

NCT04393974 | Completed DMC

• 1 other identifier: 282140
• Study Type: observational
• Target: 3,820
• Locations: 6 countries
• Sites: 25

Brief Summary

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

Conditions

Cancer; Sars-CoV2

Outcome Measures

Primary Outcomes (2)

• 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

  2 years

• 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

  2 years

Study Arms (1)

Cancer patients with COVID-19

All 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (25)

Institut Jules Bordet

Brussels, Belgium

Location

Institut Gustave Roussy

Villejuif, France

Location

Ludwig-Maximilians-Universität München

Munich, Germany

Location

Azienda Ospedaliero Universitaria SS. Antonio e Biagio e Cesare Arrigo

Alessandria, Italy

Location

ASST Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, Italy

Location

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, Italy

Location

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, Italy

Location

Azienda Istituti Ospitalieri di Cremona

Cremona, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Location

Humanitas Research Hospital

Milan, Italy

Location

Azienda Ospedaliero Universitaria Maggiore della Carità di Novara

Novara, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Location

Policlinico Universitario Campus Bio-Medico

Rome, Italy

Location

Institut Català d'Oncologia Badalona

Badalona, Spain

Location

Hospital Clínic de Barcelona

Barcelona, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location

Institut Català d'Oncologia Hospital Josep Trueta

Girona, Spain

Location

Velindre Cancer Centre, Velindre University NHS Trust

Cardiff, CF14 2TL, United Kingdom

Location

St Bartholomew's Hopsital, Barts Health NHS Trust

London, EC1A 7BE, United Kingdom

Location

University College Hospital, University College London Hospitals NHS Foundation Trust

London, NW1 2BU, United Kingdom

Location

Guy's & St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

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

London, SW10 9NH, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

Location

Northumbria Healthcare NHS Foundation Trust

Newcastle, NE27 0QJ, United Kingdom

Location

Related Publications (6)

• 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.

  PMID: 36898391 DERIVED

• 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.

  PMID: 36720089 DERIVED

• 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.

  PMID: 36450384 DERIVED

• 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.

  PMID: 35704976 DERIVED

• 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.

  PMID: 35660139 DERIVED

• 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.

  PMID: 34741822 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• David J Pinato, Prof.

  Clinical Professor of Experimental Cancer Therapeutics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 19, 2020
• Study Start: April 1, 2020
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

ES (5); BE (1); IT (10); FR (1); DE (1); GB (7)