CARDS [COVID-19]
Research type
Research Study
Full title
Cancer: Rapid Diagnostics and Immune assessment for SARS-CoV-2
IRAS ID
282755
Contact name
Sheela Rao
Contact email
Sponsor organisation
The Royal Marsden NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Summary of Research
Cancer patients are vulnerable as their immune systems are weak due to cancer and due to treatment like chemotherapy. COVID-19 is a serious viral infection that can affect people of all ages but is likely to impact cancer patients differently due to their weakened immune systems. It is very important to understand how COVID-19 affects cancer patients and whether they take longer to clear the virus. Additionally we have delayed treatment in our cancer patients (including surgery, radiotherapy and chemotherapy ) and need effective and quick testing to know when we can safely plan and restart treatment . We need to know if the new antibody testing planned for patients without cancer is also effective for cancer patients or whether the timelines are different in cancer patients. This study will test how long it takes cancer patients to clear the virus and hopefully establish an effective and rapid diagnostic antibody test to know if patients have recovered from the virus. This will then allow us to restart treatment and plan future treatment safely for our cancer patients .
Summary of Results
CCR No 5287 - CARDS - Cancer: Rapid Diagnostics and Immune assessment for SARS-CoV-2 (COVID-19).
CI and Sponsor names: Dr Sheela Rao – The Royal Marsden NHS Foundation Trust.
Study opening date: 26/05/2020 Study closing date: 29/06/2021
Proposal and Objectives:
The COVID-19 pandemic has had a significant impact on people with gastrointestinal cancers. During the initial peak of the COVID-19 pandemic in March-April 2020 there was heightened concern of the clinical sequelae of acute COVID-19 infection in people with cancer who often have a lowered immune system. People with cancer were deemed vulnerable and at a high risk of death/poor outcome in the event of COVID-19 infection. Patients were asked to shield and were often interrupting or stopping their cancer treatment. Vaccines have been effective in reducing death and hospitalisation from COVID-19, however clinical studies did not enrol people with cancer. Therefore, the effectiveness of vaccines in people with cancer is unclear.
The initial aim of the CARDS study was to characterise the clinical course of acute COVID-19 infection amongst people with cancer. To achieve this, we proposed to analyse nose/throat swabs and blood for clinical data from 50 people with cancer who had a recent COVID-19 infection.
With the downturn in the incidence of acute COVID-19 due to the nationwide lockdown from March to June 2020, the goal of the study pivoted towards exploring the COVID-19 immune status amongst people with gastrointestinal cancers receiving cancer therapy. In particular, we aimed to describe response of the immune system to previous COVID-19 infection or vaccination.Main Findings:
Between September 2020 and April 2021, 152 participants were enrolled in the CARDS study. Approximately 500 blood samples were collected and were analysed by our collaborators at St Georges University London.
Despite the immune suppressing effects of chemotherapy, people undergoing chemotherapy for the treatment of gastrointestinal cancers are able to develop immune responses to SARS-CoV-2 vaccines.
The effectiveness of the vaccines is likely to wane as soon as 20-39 days and booster vaccine doses are recommended.
Implications for practice/future research:
The results from the CARDS study will provide insights into the effectiveness of the two dose COVID-19 vaccination schedule in people with gastrointestinal cancers receiving anti-cancer therapy.
When considering whether to have chemotherapy, people with gastrointestinal malignancies can be reassured that the immune system will produce a protective response and it is recommended these patients receive the COVID19 vaccination. Decreases in protective immunity are seen within 3-6 weeks of receiving the second dose of COVID-19 vaccination. Our results reaffirm the Joint Committee on Vaccination and Immunisation (JCVI) recommendations for booster doses, particular in people with weakened immune systems.
Dissemination Plan:
Results will be made available on https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbRehJ-2Fi4xyo44sEgJVCl5Bd-2B7czg69ARM6doaqp5OcUTQs2h_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YIuSNeiKZeTHWRqsJyHsLA-2BSSq2i4N9Y0wkr2pRhlqyPMCqXq7QuL-2FySoh3B03B2-2BaoTz-2BJg7yxA-2BRaOHyHJR-2FRzgCXUf7LJhnZwQ43PbupfviPEg-2F15L1QJ-2BEqxkPcSc77y6i5-2BQi-2BvUVIuW3bwBWt18r7hBcLOhBr6iyx64ljqMvnQtvH3EC9tEBzbJWBZSs-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C21dc7dc1113842a3eaf108dab039467f%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638016057285184015%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=0AU8SqS3oW0eb0JU4eJEHaAAer%2FjnlPf58yiLrPH4Ls%3D&reserved=0 or are available on request from the research team as per the Patient Information Sheet. They will also be published in peer reviewed scientific journals and may be presented at conferences.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
20/NE/0139
Date of REC Opinion
19 May 2020
REC opinion
Further Information Favourable Opinion