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COVID-19 and Cancer Patients (OnCovid)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04393974
Recruitment Status : Recruiting
First Posted : May 19, 2020
Last Update Posted : July 15, 2022
Sponsor:
Information provided by (Responsible Party):
Imperial College London

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

Condition or disease
Cancer Sars-CoV2

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: OnCovid: Natural History and Outcomes of Cancer Patients During the COVID19 Epidemic
Actual Study Start Date : March 24, 2020
Estimated Primary Completion Date : March 24, 2023
Estimated Study Completion Date : March 24, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Describe presenting characteristics and severity or SARS-CoV-2 infection in patients with cancer [ Time Frame: 2 years ]
    Compiling a list of symptoms experienced by patients recruited onto the trial

  2. Assessing what factors are involved in prognosis of cancer patients with COVID-19 [ Time Frame: 2 years ]
    Evaluate prognostic factors for survival in patients with SARS-CoV-2 infection and cancer


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

The investigators will evaluate and include consecutive patients observed in the outpatients and inpatients facility of the study centre meeting all the following CRITERIA:

  1. Be ≥18 years of age.
  2. Have a confirmed diagnosis of malignancy of any type.
  3. Have a confirmed diagnosis of SARS-CoV-2 infection.

Exclusion Criteria:

Patients will not be entered in the study database when one or more of the following CRITERIA are present:

  1. Unconfirmed diagnosis of SARS-CoV-2 infection
  2. Insufficient clinical/follow up data.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04393974


Contacts
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Contact: David J Pinato, MD +44 (0) 207 594 1862 david.pinato@imperial.ac.uk

Locations
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United Kingdom
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom, W12 0HS
Contact: David J Pinato, MD       david.pinato@imperial.ac.uk   
Principal Investigator: David J Pinato, MD         
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: David J Pinato, MD Clinical Senior Lecturer and Consultant in Medical Oncology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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.
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.
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.

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT04393974    
Other Study ID Numbers: 282140
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: July 15, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No