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Risk of severe COVID-19 outcomes for people affected by blood cancer.

Status

Approved

Title

Risk of severe COVID-19 outcomes for people affected by blood cancer.

What is the aim of the study and why is it important?

In the global fight against COVID-19, researchers have made great progress in developing treatments to help reduce the virus's impact. However, people with blood cancer face unique and ongoing challenges when it comes to COVID-19. Our research aims to understand better how COVID-19 treatments are being used and their risks and benefits for this vulnerable group. Following development of COVID-19 vaccines, some increased risks of myocarditis[1], thromboembolic events[2], and neurological disorders[3] following vaccination were reported in the general population. Initial evidence also suggested that groups with blood cancers may have poorer response to vaccination, but there were few studies of the effectiveness and safety of COVID-19 vaccines for these groups. Therefore, there was an urgent need to assess the impact of COVID-19 vaccines in individuals with blood cancers and other blood disorders. Through our Blood Cancer UK funded research, we evaluated the uptake, safety and effectiveness of COVID-19 vaccinations among people with blood cancer using data recorded until April 2022. We found that COVID-19 vaccination is safe and effective in blood cancer patients[4] but that uptake declines following the second dose[5]. We also found marked ethnic and social disparities in COVID-19 vaccine uptake in blood cancer populations,[5] underscoring the urgent need for enhanced and targeted communication of the benefits of vaccination to these vulnerable groups.

Independent analyses are needed to continually monitor uptake, safety and effectiveness of COVID-19 therapeutics to inform policy development, even when the NIHR and DHSC have limited funding for COVID-19 research or have other priorities. The speed at which SARS-CoV-2 mutations can occur as well as the plethora of new therapeutics which have become available underscore the need to evaluate risks and benefits of COVID-19 interventions and to ensure we remain ‘research ready’. This will allow us to supply evidence to inform national policy as well as the clinical decisions made every day by those most at risk of severe outcomes from COVID-19. This is especially important for those groups of patients with longer-term conditions, who we know are vulnerable, including patients with blood cancer.

Recent advances in the availability of specialised datasets for research, which the applicants already have access to with regular refreshes, include (a) the line listing of chemotherapy data from the Systematic Anti-Cancer Treatment (SACT) database, (b) detailed radiotherapy data, (c) specialised commissioned treatment data for nMABS and antivirals, (d) cancer registry data, (e) hospital episode statistics, (f) COVID-19 infection and vaccination data and (g) contemporaneous data from primary care. Taken together, these provide a significant opportunity to evaluate not only the changing effects of the virus and the risks and benefits conferred by COVID-19 therapeutics, but also to better characterise the population of patients by type of blood cancer. It also offers the opportunity to analyse more granular information on the impact of different types of chemotherapy and radiotherapy and the timing of administration on the individual risk for someone with blood cancer. Lastly, we are now able to extend our work to cover patients of all ages, which is especially important given the numbers of children and young adults affected by blood cancers nationally[6].

We therefore propose a further program of work to significantly advance understanding of the uptake, safety and effectiveness of COVID-19 therapeutics among patients with different types of blood cancer.

Chief Investigator

Professor Julia Hippisley-Cox

Lead Applicant Organisation Name

Sponsor

Oxford

Location of research

University of Oxford

Date on which research approved

08-Aug-2024

Project reference ID

OX317

Generic ethics approval reference

23/EM/0166

Are all data accessed are in anonymised form?

Yes

Brief summary of the dataset to be released (including any sensitive data)

General Practice data -

Read/SNOMED codes referring to the following:
Diagnoses of haematological malignancies (inc. leukaemia, lymphoma, myeloma, etc.).
Diagnoses of other blood disorders (sickle cell disease, sickle cell trait, aplastic anaemia)
Self-reported ethnicity (as per Office for National Statistics classification)
Geographical region in England (n=10) These are East Midlands, East of England, London, North East, North West, South Central, South East, South West, West Midlands, Yorkshire and Humber
Body mass index (BMI)
Townsend deprivation score
Prescriptions of immunosuppressant medications
Residential status (care home resident, lives in own home, homeless)

Co-morbidities included in QCOVID:
Cardiovascular diseases (atrial fibrillation, coronary heart disease, heart failure, congenital heart disease, peripheral vascular disease)
Respiratory diseases (asthma, chronic obstructive pulmonary disease, cystic fibrosis, bronchiectasis, pulmonary hypertension)
Diabetes diagnosis (any type 1 and type 2 diabetes)
Osteoporotic fracture of hip, spine, wrist or humerus
Chronic kidney diseases (stage 3-5)
Cirrhosis of liver
Neurological and psychiatric conditions (epilepsy, stroke/TIA, motor neurone disease, multiple sclerosis, myasthenia gravis, Huntington's disease, Parkinson's disease, dementia, cerebral palsy, learning disability, severe mental illness)
Immune and haematological conditions (rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, HIV/AIDS, thrombosis)
Lung or oral cancer
Bone marrow transplantation
Solid organ transplantation
Previous COVID-19 vaccination uptake


Potential complications of COVID-19 vaccination (venous thromboembolism, cerebral venous sinus thrombosis, anaphylaxis, immune thrombocytopenia, Guillain-Barre syndrome; these will be analysed separately)
Linkage to SACT (chemotherapy) database – chemotherapy use (drug/combination)

Hospital Episode Statistics - Admitted Patients -
APC Date of admission and discharge & clinical codes relating to key outcomes

Hospital Episode Statistics - Critical Care -
CC date of admission to critical care, clinical outcome, date of discharge

COVID-19 Infection (SGSS) -
Positive SARS-CoV-2 rt-PCR tests (linkage to NHS Digital SGSS database; data on strain of SARS-CoV-2 if available, e.g. Delta variant)

COVID-19 Vaccination -
COVID-19 vaccinations (type, number of doses, dates)

Civil Registration (Mortality) -
Deaths occurring during the study period (including causes thereof, primary and secondary [up to 13])

Cancer Registry -
Recorded diagnoses of haematological malignancies, and other cancers of interest (used to define/restrict comparison groups for the analyses)

Haematological malignancies will be subdivided into leukaemias (e.g. ALL, AML, CML, CLL), lymphomas, and other relevant groups.

Public Benefit Statement

Research Team

Professor Carol Coupland (University of Nottingham)

Dr Jenny Hirst (University of Oxford)

Miss Emma Copland (University of Oxford)

Dr Daniel Chen (University of Oxford)

Access Type

Trusted Research Environment (TRE)

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