THE ONCOVID STUDY
BACKGROUND AND RATIONALE
Coronaviruses are a large family of viruses that are common in people and many different species of animals. Rarely, animal coronaviruses can infect people and then spread between people such as with MERS-CoV, SARS-CoV, and now with this new virus (named SARS-CoV-2).
The World Health Organisation (WHO) declared the coronavirus outbreak a pandemic on 11th March 2020, and it has now been officially recognised that the spread of COVID-19 is expected to affect most countries in the world.
The complete clinical picture with regards to COVID-19 is not fully known. Reported illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. While information so far suggests that most COVID-19 illness is mild, a report out of China suggests serious illness occurs in 16% of cases. Older people and people of all ages with severe chronic medical conditions — like heart disease, lung disease and diabetes, for example — seem to be at higher risk of developing serious COVID-19 illness. A CDC Morbidity & Mortality Weekly Report that looked at severity of disease among COVID-19 cases in the United States by age group found that 80% of deaths were among adults 65 years and older with the highest percentage of severe outcomes occurring in people 85 years and older.
The morbidity and mortality stemming from COVID-19 infection in cancer patients is not fully appreciated. Patients with cancer often have multiple co-morbid conditions and are often immune-suppressed as a result of their malignancy or systemic anti-cancer treatment.
The overarching purpose of this retrospective, non-interventional study is to describe the features of COVID-19 infection in cancer patients, investigate its severity in this population and evaluate long-term outcomes by means of medical charts review of consecutive patients co-diagnosed with SARS-CoV-2 infection and malignancy.
STUDY DESIGN AND METHODS
1. Describe presenting characteristics and severity of SARS-CoV-2 infection in patients with cancer.
2. Evaluate prognostic factors for survival in patients with SARS-CoV-2 infection and cancer.
Patients with a diagnosis of malignancy and SARS-CoV-2infection will be identified from electronic medical records and entered into a pre-designed database.
Methodologically, this project will be limited to secondary use of information previously collected in the course of normal care (without an intention to use it for research at the time of collection). Every aspect of this project will be undertaken by staff within a care team using information previously collected in the course of care for their own patients.
Routinely collected clinical information including patients’ demographics, prior medical history, cancer history including prior and current anti-cancer therapy, co-morbidities will be collected in a data collection proforma. Results of routinely collected blood tests, radiologic assessments and therapies received by the patient will also be entered onto the database. Clinical outcomes including response to treatment and patients’ survival will be evaluated in relationship to baseline clinico-pathologic profile. Clinico‐pathologic will be correlated to patient’s outcome, in particular overall survival (OS) as derived from electronic medical records.
The database consists of a Microsoft Excel spreadsheet including the following variables: age, gender, smoking status, prior comorbidities (cardiovascular, diabetes, dementia, pulmonary and kidney disease, liver disease, hypertension, immunesuppression), histotype of malignancy, date of first cancer diagnosis and stage of cancer at the time of SARS-CoV-2 infection, prior and current anti-cancer therapy, presenting symptoms at SARS-CoV-2 diagnosis and severity, routine blood tests at SARS-CoV-2 diagnosis (routine biochemistry, full blood count), radiologic data at diagnosis and follow up data (admission to intensive care, anti SARS-CoV-2-specific therapy, complications from SARS-CoV-2 infection).
Data collection will be completely solely by members of the patients’ team. Resulting clinical data will be fully anonymised and stored in a password-protected NHS computer.
Subject number and selection
We plan to collect descriptive data in all consecutive patients with confirmed diagnosis of SARS-CoV-2 infection and cancer. Due to the descriptive and retrospective nature of this study, no sample size is required for hypothesis testing. We aim to describe clinical outcomes of consecutively presenting patients with a diagnosis of cancer and SARS-CoV-2 infection and aim to retrieve data on up to 100 fulfilling eligibility 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.
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.