CancerNCT04603105
CCP Cancer UK Companion Study
An observational study of Cancer and Covid19, run by The Clatterbridge Cancer Centre NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Any age
- How many people
- 9,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Feb 2021to 31 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- Patients with proven COVID-19 and a diagnosis of cancer who are enrolled into any Tier of the Principal CCP-UK protocol.
Who cannot join
- None in addition to those specified in the Principal CCP-UK protocol.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, L78YA
About this study
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
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
Read the 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.
- Medical subject headings
- Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single Study Cohort | Patients will be recruited from the main study after being determined to having COVID-19 and Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the COVID-19 fatality rate overall in the cancer population using the most up to date dataset from the first wave.
Death rate among cohort of cancer and COVID-19 patients
Measured: 12 months
To determine the COVID-19 fatality rate in different tumour types.
Exploring the number of deaths per group when sub grouping tumour types
Measured: 12 months
Secondary outcomes (5)
To describe the clinical features and severity of COVID-19 in different tumour types.
Comparison of the outcomes in COVID-19 across various tumour groups
Measured: 12 months
To identify other clinical and laboratory variables that correlate with COVID-19 severity and mortality in different tumour types.
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
Measured: 12 months
To determine the influence of disease stage, treatment intent and treatment history on severity and COVID-19 fatality rate.
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.
Measured: 12 months
To describe the use of healthcare resources (including intensive care) in the treatment of COVID-19 in different tumour types.
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.
Measured: 12 months
To undertake a matched cohort study using the cancer and non-cancer patients with COVID-19.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start28 Feb 2021
- Primary completion31 Oct 2024
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Clatterbridge Cancer Centre NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Edinburgh, University of Oxford, University of Liverpool
- Responsible party
- Sponsor
- Investigators
- Carlo Palmieri, Principal investigator, Clatterbridge Cancer Centre NHS Foundation TrustLance Turtle, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603105
- Sponsor's protocol ID
- C1147
- Status last verified
- Feb 2025
- First submitted
- 9 Oct 2020
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04603105
- Acronym / sponsor ID
- C1147
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 9,000 participants (actual)
- Lead sponsor
- The Clatterbridge Cancer Centre NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Edinburgh, University of Oxford, University of Liverpool
- Study start
- 28 Feb 2021 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 26 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Study Cohort | – | –Patients will be recruited from the main study after being determined to having COVID-19 and Cancer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients with proven COVID-19 and a diagnosis of cancer who are enrolled into any Tier of the Principal CCP-UK protocol.
Key exclusion criteria (1 listed)
- None in addition to those specified in the Principal CCP-UK protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
5 secondary outcomes
To describe the clinical features and severity of COVID-19 in different tumour types.
Time frame: 12 months
To identify other clinical and laboratory variables that correlate with COVID-19 severity and mortality in different tumour types.
Time frame: 12 months
To determine the influence of disease stage, treatment intent and treatment history on severity and COVID-19 fatality rate.
Time frame: 12 months
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 undertake a matched cohort study using the cancer and non-cancer patients with COVID-19.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo Palmieri principal investigator
Clatterbridge Cancer Centre NHS Foundation Trust
Lance Turtle principal investigator
University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Covid19, run by The Clatterbridge Cancer Centre NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.