COVID-19 and Cancer Patients

Cancer Clinical Trial

— OnCovid  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04393974
• Other study ID #: 282140
• Status: Recruiting
• Start date: March 24, 2020
• Est. completion date: March 24, 2024

Study information

• Verified date: July 2022
• Source: Imperial College London
• Contact: David J Pinato, MD
• Phone: +44 (0) 207 594 1862
• Email: david.pinato[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 24, 2024
• Est. primary completion date: March 24, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Sars-CoV2

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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