COVID-19 and Cancer Patients

NCT ID: NCT04393974

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3820 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2024-04-01

Brief Summary

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

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David J Pinato, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Senior Lecturer and Consultant in Medical Oncology

Locations

Imperial College Healthcare NHS Trust

London, , United Kingdom

Countries

United Kingdom

References

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Reference Type: DERIVED

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Reference Type: DERIVED

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Reference Type: DERIVED

PMID: 34741822 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

282140

Identifier Type: -

Identifier Source: org_study_id