OnCovid: Natural History and Outcomes of Cancer Patients During the COVID19 Epidemic
Conditions: Cancer, Sars-CoV2
Sponsor: Imperial College London

 
 
             
 
 
 
 
 
 
 
 
 
 
RESEARCH STUDY PROTOCOL 
 
 
 
 
 
Title: 
OnCovid: natural history and outcomes of cancer patients 
during the COVID19 epidemic. 
 
 
Protocol Version: 
 
Version 3.0 dated 1st June 2020 
 
Chief Investigator:   
Dr David James Pinato 
 
Sponsor:  
 
 
Imperial College London 
 
IRAS Project ID: 
 
282140 
 
 
 
 
 

 
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SYNOPSIS 
 
Study title: 
OnCovid19: natural history and outcomes of cancer patients during the 
COVID19 epidemic.  
 
  
 
Objectives:   
To describe the natural history and clinical outcomes of patients with cancer 
and Covid19 infection.  
 
Study design & 
methodology: 
Retrospective observational study. 
 
 
Research 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 research 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 data 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 assessment 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. 
 
 
Duration of  
Research: 
2 years 
 
Planned sample    
size: 
 
 
 
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 5000 fulfilling eligibility 
criteria.  

 
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Summary of 
eligibility 
criteria:  
 
Inclusion 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.  
 
Number of study 
centres: 
 
1 
Endpoints: 
To retrospectively describe the survival of cancer patients affected by SARS-
CoV-2 infection.   
  
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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General Study Information 
 
Name of 
sponsor:                         
Imperial College London 
Joint Research Compliance Office 
Room 221 
Medical School Building 
St Mary’s Campus 
Norfolk Place 
London, W2 1PG 
 
Contact: Becky Ward 
Research Governance Manager 
Email: becky.ward@imperial.ac.uk 
Tel: +44 (0) 207 594 9459 
 
Principal investigator: Dr David James Pinato 
Clinical Senior Lecturer and Consultant in Medical 
Oncology 
Imperial College London 
Level 1 ICTEM Building, Room 138 
Hammersmith Hospital 
Du Cane Road 
London W12 0NN 
Email: david.pinato@imperial.ac.uk 
Tel: +44 (0) 207 594 1862 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Co-investigators: 
 
 
 
 
 
 
 
 
 
Prof. Mark Bower, MA MB Bchir PhD FRCP 
FRCPath 
 
Consultant Medical Oncologist,  
Chelsea and Westminster NHS Foundation Trust 
369 Fulham Road 
SW109NH 
London 
 
 
Dr. Diego Ottaviani, MBBS PhD 
NIHR Academic Clinical Fellow in Medical Oncology 
University College London Hospitals 
250 Euston Road 
SW12PG 
London 
 
 
 
Data analyst 
 
 
 
 
 
 
 
Professor Hulbert-Williams 
 
 
 
 
Clinical Psychologist, Professor of Behavioural Medicine 
The University of Chester 
Parkgate Road,  
Chester  
CH1 4BJ 
 
 

 
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1.0 BACKGROUND AND RATIONALE 
1.1 
Introduction 
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.  
 
2.0  STUDY OBJECTIVES 
 
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. 
 

 
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3.0 STUDY DESIGN AND METHODS 
3.1 
Endpoints 
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.  
 
3.2 
Methods 
Patients with a diagnosis of malignancy and SARS-CoV-2 infection 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. 
 
 

 
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4.0 SUBJECT POPULATION 
4.1 
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 5000 fulfilling eligibility criteria.  
 
  
4.1.1 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: 
 
Inclusion 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.  
 
4.1.2 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. 
 
 
 
 

 
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5.0 STATISTICAL ANALYSIS 
5.1 
Subject numbers. 
5.1.1  Sample size. 
For this observational, retrospective study, we propose a sample size of 5000 patients. Given the 
descriptive nature of this study no formal hypothesis testing is required. We will be retrospectively 
including patients fulfilling eligibility criteria between 1st January 2020 and 1st of April 2020. 
5.2 
Statistical methods. 
Analysis of overall survival (OS) will validate the prognostic value of each clinico-pathologic trait 
collected at treatment initiation. Univariable analysis of survival will be used to derive median OS 
and associated 95% CI by using Kaplan-Meier methods and Log-rank tests. 
The HRs and their associated CIs for OS will be computed using unadjusted and adjusted Cox 
proportional hazards models. We will employ a backward stepwise conditional model where each 
variable with an entry threshold of p<0.05 and an exit threshold of p<0.10 at each iteration. 
Proportional hazards will be adjusted for factors including active anticancer treatment type and 
features reflective of SARS-CoV-2 infection. Receiver-operating characteristics curve (ROC) will 
be used to test each variable for the accuracy of prediction of mortality at landmark survival 
endpoints (ie. 8, 12 weeks). 
To test the predictive accuracy of each candidate prognostic variable we will use Harrell’s rms 
packages to identify a subset of predictors by backward elimination, estimating the confidence 
intervals of the c-index statistics via bootstrapping (150 iterations). 
 
6.0 DATA MANAGEMENT 
 
Data will be collected and retained in accordance with the Data Protection Act 2018. The data 
collected from the study will be entered in a study specific database by designated staff. The 
database will be kept on a secure NHS computer. Access to the database will be given to authorised 
personnel only and log of access will be kept in the study file by the Principal Investigator. 
 

 
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7.0 REGULATORY ISSUES  
 
7.1 
Ethics Approval 
 
In view of the retrospective nature of this study, approval from a Research Ethics Committee within 
the UK Health Departments Research Ethics Service is not necessary. and Health Research 
Authority (HRA). The criteria for REC review exemption is: 
 
Research involving previously collected, non-identifiable information 
 
Research 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) is generally excluded from REC 
review, provided that the patients or service users are not identifiable to the research team in 
carrying out the research. This exception also applies to research undertaken by staff within a care 
team using information previously collected in the course of care for their own patients or clients, 
provided that data is anonymised or pseudonymised in conducting the research. 
 
The study will be conducted in accordance with the recommendations for physicians involved in 
research on human subjects adopted by the 18th World Medical Assembly, Helsinki 1964 and later 
revisions.   
7.3  
Confidentiality 
 
A unique reference number will be used to anonymize the details of all participants. The investigator 
must ensure that the patient’s privacy is maintained at all times. On the Case Report Form (CRF) 
or other documents, patients will be identified by a study ID number only. The investigator shall 
permit direct access to study source document for the purposes of monitoring, auditing, or 
inspection by the Sponsor, authorised representatives of the Sponsor and Regulatory Authorities. 
7.4 
Indemnity 
 
Imperial College London holds negligent harm and non-negligent harm insurance policies which 
apply to this study. 
7.5 
Sponsor 
 

 
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Imperial College London will act as the main Sponsor for this study.  Delegated responsibilities 
will be assigned to the NHS trusts taking part in this study. 
7.6 
Audits 
The study may be subject to inspection and audit by Imperial College London under their remit as 
sponsor and other regulatory bodies to ensure adherence to GCP and the UK Policy Frame Work 
for Health and Social Care Research. 
 
7.8 
Publication Policy 
 
A whole or part of the study results will be communicated, orally presented, and/or published in 
appropriate scientific journals. Full anonymity of subject’s details will be maintained throughout. 
Subjects wanting to see the results of the trial can request a copy of the article from the 
investigators once it has been published. 
 
8.0 STUDY MANAGEMENT 
 The day-to-day management of the study will be co-ordinated through the Cancer Research 
office at Hammersmith Hospital.   
 
 
 

 
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10.0 REFERENCES 
 
 
1: Phan T. Novel coronavirus: From discovery to clinical diagnostics. Infect Genet Evol. 2020 Apr;79:104211. 
doi: 10.1016/j.meegid.2020.104211. Epub 2020 Jan 30. PubMed PMID: 32007627. 
 
2: Elston DM. The coronavirus (COVID-19) epidemic and patient safety. J Am Acad Dermatol. 2020 
Apr;82(4):819-820. doi: 10.1016/j.jaad.2020.02.031. Epub 2020 Feb 16. PubMed PMID: 32074487. 
 
3: Kofi Ayittey F, Dzuvor C, Kormla Ayittey M, Bennita Chiwero N, Habib A. Updates on Wuhan 2019 novel 
coronavirus epidemic. J Med Virol. 2020 Apr;92(4):403-407. doi: 10.1002/jmv.25695. Epub 2020 Feb 10. 
PubMed PMID: 32017153. 
 
4: Li G, Fan Y, Lai Y, Han T, Li Z, Zhou P, Pan P, Wang W, Hu D, Liu X, Zhang Q,  Wu J. Coronavirus 
infections and immune responses. J Med Virol. 2020 Apr;92(4):424-432. doi: 10.1002/jmv.25685. Epub 2020 
Feb 7. Review. PubMed PMID: 31981224. 
 
5: Ji Y, Ma Z, Peppelenbosch MP, Pan Q. Potential association between COVID-19 mortality and health-care 
resource availability. Lancet Glob Health. 2020 Apr;8(4):e480. doi: 10.1016/S2214-109X(20)30068-1. Epub 
2020 Feb 25. PubMed PMID: 32109372. 
 
6: Wang T, Du Z, Zhu F, Cao Z, An Y, Gao Y, Jiang B. Comorbidities and multi-organ injuries in the treatment 
of COVID-19. Lancet. 2020 Mar 21;395(10228):e52. doi: 10.1016/S0140-6736(20)30558-4. Epub 2020 Mar 
11. PubMed PMID: 32171074. 
 
 
 
 
 
 
 
 
 
 
 

 
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11. PROTOCOL SIGNATURE PAGE 
 
 
 
I agree to conduct the Study in accordance with the approved protocol. 
 
 
I agree to comply with the procedures for data recording/reporting 
 
 
Name of Principal Investigator:  
 
Signature: 
 
 
Date: