CCP Cancer UK Companion Study

• ClinicalTrials.gov Identifier: NCT04603105
• Recruitment Status: Not yet recruiting
• First Posted: October 26, 2020
• Last Update Posted: January 5, 2021
• Sponsor: The Clatterbridge Cancer Centre NHS Foundation Trust
• Collaborators: University of Edinburgh; University of Oxford; University of Liverpool
• Information provided by (Responsible Party): The Clatterbridge Cancer Centre NHS Foundation Trust

Study Description

Brief 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

Condition or disease
Cancer; Covid19

Detailed 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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 9000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Clinical Characterisation Protocol for Severe Emerging Infections in the UK (CCP-UK) - a Prospective Companion Study for Patients With Cancer and COVID-19
• Estimated Study Start Date: February 28, 2021
• Estimated Primary Completion Date: October 31, 2021
• Estimated Study Completion Date: October 31, 2022

Groups and Cohorts

Group/Cohort
Single Study Cohort; Patients will be recruited from the main study after being determined to having COVID-19 and Cancer

Outcome Measures

Primary Outcome Measures :

1. To determine the COVID-19 fatality rate overall in the cancer population using the most up to date dataset from the first wave. [ Time Frame: 12 months ]
   Death rate among cohort of cancer and COVID-19 patients
2. To determine the COVID-19 fatality rate in different tumour types. [ Time Frame: 12 months ]
   Exploring the number of deaths per group when sub grouping tumour types

Secondary Outcome Measures :

1. To describe the clinical features and severity of COVID-19 in different tumour types. [ Time Frame: 12 months ]
   Comparison of the outcomes in COVID-19 across various tumour groups
2. To identify other clinical and laboratory variables that correlate with COVID-19 severity and mortality in different tumour types. [ Time Frame: 12 months ]
   The rate of death and outcomes in COVID-19 will be subgrouped across various tumour types and compared against various clinical and laboratory indicators from the dataset and translational analysis
3. To determine the influence of disease stage, treatment intent and treatment history on severity and COVID-19 fatality rate. [ Time Frame: 12 months ]
   Trends in stage of cancer at COVID-19 diagnosis, the treatment modalities administered both concurrently and previously will be compared against poorer outcomes and sequela for trends. Severity and Frailty with be stratified across all 3 factors, this is one outcome.
4. To describe the use of healthcare resources (including intensive care) in the treatment of COVID-19 in different tumour types. [ Time Frame: 12 months ]
   To compare the admission time, interventions and assessments needed for the treatment of COVID-19 across various Tumour types. For each tumour type, the admission, intervention and assessments will be collated and compared with other tumour types. This is one outcome.
5. To undertake a matched cohort study using the cancer and non-cancer patients with COVID-19. [ Time Frame: 12 months ]
   The Cancer Data set will be linked with the main CCP UK study for an overall comparison in COVID-19 outcomes and interventions in patient who have cancer and those who do not have cancer

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Patients who are enrolled on to the CCP UK protocol study with COVID-19 and subsequently determined to have a concurrent or history of cancer

Criteria

Inclusion Criteria:

- Patients with proven COVID-19 and a diagnosis of cancer who are enrolled into any Tier of the Principal CCP-UK protocol.

Exclusion Criteria:

- None in addition to those specified in the Principal CCP-UK protocol.

Contacts and Locations

Contacts

Contact: Michael Stacckpoole, Bsc; 0151 795 7321; ccpcanceruk@liverpool.ac.uk

Contact: Molly Mcevoy; 01517948248; mmcevoy@liverpool.ac.uk

Sponsors and Collaborators

The Clatterbridge Cancer Centre NHS Foundation Trust

University of Edinburgh

University of Oxford

University of Liverpool

Investigators

• Principal Investigator: Carlo Palmieri; Clatterbridge Cancer Centre NHS Foundation Trust
• Principal Investigator: Lance Turtle; University of Liverpool

More Information

• Responsible Party: The Clatterbridge Cancer Centre NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT04603105
• Other Study ID Numbers: C1147
• First Posted: October 26, 2020
• Last Update Posted: January 5, 2021
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: The Cancer cohort data is being shared with the University of Edinburgh, within their data safe haven, in order to link with main cohort data. The UoE safe haven is part of the CCP Cancer study and not external researchers.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases