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Clinical Trials/NCT04393974
NCT04393974
Completed
N/A

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

Imperial College London25 sites in 6 countries3,820 target enrollmentApril 1, 2020
ConditionsCancerSars-CoV2

Overview

Phase
N/A
Intervention
Cancer patients with COVID-19
Conditions
Cancer
Sponsor
Imperial College London
Enrollment
3820
Locations
25
Primary Endpoint
Describe presenting characteristics and severity or SARS-CoV-2 infection in patients with cancer
Status
Completed
Last Updated
2 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2020
End Date
April 1, 2024
Last Updated
2 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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:
  • Be ≥18 years of age.
  • Have a confirmed diagnosis of malignancy of any type.
  • 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:
  • Unconfirmed diagnosis of SARS-CoV-2 infection
  • Insufficient clinical/follow up data.

Arms & Interventions

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.

Outcomes

Primary Outcomes

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

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

Study Sites (25)

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