Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04603105 |
| Other study ID # |
C1147 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 28, 2021 |
| Est. completion date |
October 31, 2022 |
Study information
| Verified date |
October 2020 |
| Source |
The Clatterbridge Cancer Centre NHS Foundation Trust |
| Contact |
Michael Stacckpoole, Bsc |
| Phone |
0151 795 7321 |
| Email |
ccpcanceruk[@]liverpool.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Currently, there is extremely limited information regarding the risks posed by SARS-CoV-2 to
patients with cancer. This study aims to understand the presentation, management and outcomes
of patients with cancer. The influence of cancer type and treatment will be explored as well
as comparing cancer patients with non-cancer patients. This dataset, on robust analysis, will
provide valuable information that would educate as well as help inform practice for future
possible outbreaks. The information may also inform the development of guidelines with regard
to the care and management of cancer patients with viruses such as COVID19 and similar
infectious diseases. Cancer is immunosuppressive, the nature of the immunosuppression seems
to be influenced by the microbiota, and in addition pulmonary infections
Description:
In December 2019 the first pneumonia cases of unknown origin were identified in Wuhan, the
capital city of Hubei province. High-throughput sequencing revealed the pathogen to be a
novel enveloped RNA betacoronavirus. Initially named 2019 novel coronavirus (2019-nCoV) it
was subsequently renamed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (2).
Transmission of SARS-CoV-2 is via respiratory droplets and direct contact, and infection
results in coronavirus disease (COVID-19). The World Health Organization (WHO) has recently
declared the SARS-CoV-2 outbreak a public health emergency of international concern on 30th
January 2020, and a global pandemic on 11th March 2020.
The clinical characteristics of COVID-19 are typically fever, dry cough and fatigue,
sometimes accompanied by sore throat, chest discomfort and difficulty breathing. However, a
wide range of other symptoms are possible, including gastrointestinal symptoms such as
nausea, vomiting, loss of appetite, abdominal pain and diarrhoea. Loss of taste and smell
have also been described.
Individuals with malignant disease are more prone to respiratory viruses than individuals
without cancer as a result of immunosuppression caused by either the underlying disease
process or systemic anti-cancer therapy. The death rate from influenza in patients with solid
organ tumours is much higher than expected for the background population, even allowing for
likely ascertainment bias. This is reflected in individuals with cancer being recommended to
receive the seasonal flu vaccination. Certain groups of cancer patients are even more prone
to infection. For example, patients with haematological malignancy undergoing bone marrow
transplantation have significant mortality even with rhinovirus, which can double the
transplant related mortality. There is currently no prospective robust data regarding the
presentation, management and outcome of patients with COVID-19 with cancer who are
immunocompromised as result of either the disease or treatment. Furthermore, it is not clear
if the immunosuppressive effects of systemic anti-cancer therapy such as chemotherapy are the
same across all cancer types and the possible risks entailed by targeted therapies and
immunotherapy. Currently, cancer patients on treatment are considered at high risk group of
possible severe infection with SARS-CoV-2 and measures such as self-isolation are being
recommended to mitigate the risks of such patients being infected. However, information to
inform this decision, and whether any specific sub-groups of patients are at particular risk
is lacking. These data are vital to inform policy on cancer treatments as patients may be
potentially exposed to SARS-CoV-2 for a long time to come. Furthermore, given patients with
cancer are often immunosuppressed and this may alter the clinical presentation as well as
clinical course and outcomes. Different tumour types may also have implications for
SARS-CoV-2 exposure, for example patients with lung cancer may be more susceptible, and
require different pathways to ensure care can be delivered safely. This protocol aims to
describe the presentation, management and outcomes of patients with solid and haematological
malignancies with COVID-19 and compared to non-cancer patients. The CCP-CANCER UK will
provide valuable information that would educate as well as help inform current practice and
development of guidelines globally with regard to COVID19 infection in cancer patients. While
samples collected within CCP-UK from cancer patients will enable an understanding of the
biology of COVID-19 in the setting of cancer-related immunodeficiency both innate and
iatrogenic.
