COVID-19 and Cancer Patients

• Conditions: Cancer; Sars-CoV2

• Registration Number: NCT04393974
• Lead Sponsor: Imperial College London

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.

Study Timeline

• Study Start: 2020-03-24
• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-05-18
• Study First Posted: 2020-05-19
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-14
• Last Update Posted: 2022-07-15
• Primary Completion: 2023-03-24
• Study Completion: 2024-03-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Describe presenting characteristics and severity or SARS-CoV-2 infection in patients with cancer	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	2 years	Evaluate prognostic factors for survival in patients with SARS-CoV-2 infection and cancer

Trial Locations

Locations (1)

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom