UK Coronavirus cancer monitoring project

The UK Coronavirus cancer monitoring scheme is a clinician-led reporting project supported to enable tracking of cancer patients who have tested positive for COVID-19 across the United Kingdom.

The aims of this project are to ensure adequate cancer care is being delivered where required across the country and to assess the impact on cancer patients.

Image of clinician reporting on project

The project collects information about prevalence of COVID-19 infections with associated anonymised data about site of disease and mortality through our COVID-19 response reporting network. 

It is unique in providing the first example of  Live Clinical Data Dissemination System during this pandemic. This enables direct real-time daily updates back to individual Cancer Centres. This system is coordinated by the Centre for Computational Biology allowing annotation, analysis and dissemination securely through a dedicated workflow hosted by the Compute and Storage for Life Science (CaStLeS) infrastructure as part of the Birmingham Environment for Academic Research local Cloud (BEARCloud). A pushed near-real-time update is generated daily to an interactive website and reports are sent to individual UK Cancer Centres and clinicians at a weekly basis . 

The project is being co-led by Prof Gary Middleton (University Hospitals Birmingham),  Prof Rachel Kerr (Oxford University Hospitals) and Dr Lennard Lee (University Hospitals Birmingham). Senior scientific Lead is Professor Jean-Baptiste Cazier (University of Birmingham) with further scientific leadership supported provided by Dr Claire Palles, Dr Roland Arnold and Shivan Sivakumar.

FAQs

Why is this project happening?

Cancer teams across the UK are worried about the impact of COVID-19 on patients with cancer.  This project aims to bring together our cancer community to understand more about COVID-19 and its impact on those with cancer.  Our hope is that this will facilitate shared learning as efficiently and effectively as possible for all patients with cancer across the UK.

Do I need local ethical approval?

No – please see the letter from the Health Research Authority in ‘Supporting Documents’, confirming this is not research and therefore does not require NHS Ethics or Research and Development Approval. However, we advise that patients are informed and given the opportunity to opt out of inclusion where it is considered practical and reasonable to do so.

However, you will need local approval through your audit process (see below). It may be helpful to signpost your Information Governance team to the following guidance issued by the Secretary of State for Health and Social Care on sharing information relating to the Covid-19 outbreak: https://www.nhsx.nhs.uk/key-information-and-tools/information-governance-guidance/ig-professionals.

Who is the ‘Clinical Lead’ on the Centre Activation Form?

All Centres will have their own management structures.  It is intended that is an individual at your Centre who can give Directorate or Departmental approval to the project.

Is a Centre intended to be an individual hospital, a Trust or a Region?

This can be defined based on how your local cancer network is arranged.  We suggest that Cancer Networks, which usually have a central Cancer Centre hub, but may span more than one Health Board or Trust, may be the easiest structure.  However, note that when a participant is logged on the database, they will be logged by your Centre, but the descriptor will be at individual hospital level.

Does the ERRI need to be a Consultant?

No, it can be a registrar, but we recommend all registrars are supported by a named Consultant who will support the process.

Who needs to be on the LERRG?

This can be defined locally, but essentially this is the group formed at each Centre that will be responsible, with oversight from the ERRI, for submitting data to the portal.  The LERRG is the local Project group who will manage the project at a local level.

It should include a lead registrar and lead Consultant (one of whom is the ERRI), and additional members are at the discretion of each centre.  It might involve a small number of registrars, data managers, nurses or anyone who will contribute to the process locally. It is worth ensuring your LERRG and your process for data entry are themselves COVID-proof, in case individuals within the LERRG become unwell, and that more than one individual has the capacity to log cases to the database.

Can anyone add a case to the database?

Once a Centre has submitted their Centre Activation Form, they will be sent a username and password unique to their centre.  Anyone with access to these can submit a case to the database.

The process by which Centres add a case to the database can be decided locally as systems and organisational structures will vary.  For example, you may choose to set up a process where anyone at your Cancer Centre can add a case to the database, or where only the LERRG can submit a case.  You should design a process that works best for your Centre, noting that you will need to ensure continuity for Patient IDs for your centre, potential issues of duplication, and clinical governance issues as each Centre can access a summary of its own entries (see below).

Who can see the data entered into the Project?

Each Centre will be able to access all cases and download the data collected by that Centre only.  Centres will not be able to see the data entry from other Centres on an individual case level.

All data is collected on a central REDCap data platform hosted by The Institute of Translational Medicine, University of Birmingham. Each centre has a unique site code, individual username and password to the site. Inputting sites cannot see each other’s data forms. All anonymised data records are stored on secure University of Birmingham servers for the purposes of this project only.  Data is only identifiable using a key which is held by the reporting centre and must not be disclosed. As such participant data is completely de-identified within the online platform.

Who owns the data generated locally? Can a Centre use their own data generated from this database?

The aim of this project is to be as open as possible.  Data generated by a local centre therefore remains the property of that centre, but the UKCCMP should be credited if this data is used.

Do I need Caldicott approval before sending back my Centre Activation Form?

We are aware that centres have different processes for audit approval and the processes for achieving this will differ across the UK. It is possible that your centre may require Caldicott approval so this needs to be checked with you local approver/ Caldicott guardian and put in place if deemed to be required.

If centres are collating information from other hospitals within their Health Board/Trust, or from other affiliated Health Boards/Trusts this may require Caldicott approval and should be discussed with the local approver/Caldicott Guardian. This does not necessarily need to be in place before data at the Centre itself commences data collection.  However, other Trust/hospital data collection can  commence once agreements are established.

By submitting your Centre Activation Form, you are confirming that all required local approvals.  Responsibility for this lies with the Centre, and not the UKCCMP.

What safeguards are in place to protect the data shared by a Centre?

The UKCCMP has undertaken a comprehensive review of the data processing, compliance measures, risks and mitigating factors. A Data Protection Impact Assessment has been completed and approved by the Data Protection Officer at the University of Birmingham.

When will reporting begin from the database, and how will this be done?

While case numbers are small, it is important confidentiality is not inadvertently breached by reporting at a level of granularity that may make individual cases identifiable.  As such, it is intended that reporting will begin when there are sufficient cases to ensure this is not a risk.  Reporting granularity will initially be on a nation basis (Scotland, Northern Ireland, Wales, England).  It is intended that the frequency and granularity of reporting will increase once the number of cases renders it appropriate to do so.

Can I get involved with the running of the project?

This project is being run by a team of volunteers from across the UK – doctors, nurses, graphic designers, scientists, students all working out of hours and pro-bono. It is a testament of the ability of the Cancer Community to pull together. If you want to get involved in running the project, there may be scope to do so – send your details through the contact form outlining what skills you would like to volunteer.  It may be that we require certain skills as the project evolves and this will allow us to involve people in the right places.

What is the definition of 'Diagnosis of COVID19'

For complete objectivity, only cases of COVID19 confirmed via PCR or antibody testing are counted as confirmed COVID19 in this registry.  We are aware of evidence that radiological findings in the absence of a positive laboratory result is often managed clinically as a positive result, or that there can be a high clinical suspicion in individuals that are self isolating and therefore not being tested per current government guidelines. Imaging findings in COVID19 have similarities to more common respiratory conditions, including other infections and pneumonitis. For this reason to ensure integrity of the dataset, only patients with a confirmatory laboratory result will be included.

It may be that in the future antibody testing will confirm retrospectively that a patient had COVID19.  It will be possible to retrospectively add these patients to the database, so we would invite centres to consider this when keeping lists of their negative patients who are considered clinically to have a high probability of COVID19.

What is the definition of 'Active Cancer'?

Active Cancer is defined as:

  • Any patient with metastatic disease (Irrespective of status including those on treatment/ Watch and Wait / Best Supportive Care)
  • Any patient with cancer on active treatment in any setting
  • Those treated within the past 12 months with either surgery, Systemic anticancer therapies (SACT) and/or radiotherapy in the curative/radical/adjuvant/neoadjuvant setting.​

Are Haematology patients included in this dataset?

Currently we are not collecting haematology cases but this FAQ will be updated as we work with our haematology colleagues to adapt this platform.  Watch this space!

What about paediatric oncology patients?

Please see our section for Paediatric Oncology patients, available via a link on the Home Page and at https://ukcoronaviruscancermonitoring.com/paediatrics/

How should I acknowledge the UK Coronavirus Cancer Monitoring Project?

The UK Coronavirus Monitoring Project collaborative steering board comprises of Iris Anil, Roland Arnold, Sam Benkwitz-Beford, Simon Branford, Naomi Campton, Jean-Baptiste Cazier, Vinton Cheng, Helen Curley, Jamie D’Costa, Andrew Edmondson, Luke Freeman-Mills, Anshita Goel, Simon Hartley, Daniel J Hughes, Rachel Kerr, Alvin Lee, Lennard YW Lee, Naomi Longworth, Christopher Middleton, Gary Middleton, Piangfan Naksukpaiboon, Anna Olsson-Brown, Claire Palles, Emily Protheroe, Karin Purshouse, Carol Sandys, Archana Sharma-Oates, Shivan Sivakumar, Ashley Smith, Thomas Starkey, Simon Thompson, Csilla Varnai. The collaborative would like to acknowledge the time and expertise of each of its members in the deliver of this project and thank all the participating centres and emergency response reporting individuals (ERRIs) involved.