CCP Cancer UK Study. Companion study to educate and inform practice and guidelines regarding COVID-19 infection in cancer patients

ISRCTN	ISRCTN15019599
DOI	https://doi.org/10.1186/ISRCTN15019599
IRAS number	285044
ClinicalTrials.gov number	NCT04603105
Secondary identifying numbers	CPMS 46602, IRAS 285044

Submission date: 06/10/2020
Registration date: 10/11/2020
Last edited: 13/05/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.

In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. In March 2020, it was advised that people minimize travel and social contact, and regularly wash their hands to reduce the spread of the virus.

Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19, include people aged over 70 years, people who have long-term health conditions (such as asthma or diabetes), people who have a weakened immune system and people who are pregnant. People in these groups, and people who might come into contact with them, can reduce this risk by following the up-to-date advice to reduce the spread of the virus.

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, and the existence of a large dataset of COVID patients including both cancer patients and patients without cancer, allows a comparison between these two groups which can be adjusted for other confounding variables such as age and co-morbidity. The overall objective of the CCP-CANCER UK is to provide information that would educate as well as help inform current practice and development of guidelines globally with regard to COVID-19 infection in cancer patients, in both haematological and solid malignancies (ICD-10 C00x to D49x, all morphologies).

Who can participate?
Patients with COVID-19 who have with a diagnosis of a solid or haematological malignancy. The main population will be from patients who have been recruited to the UK Clinical Characterisation Protocol (CCP-UK) study.

What does the study involve?
This is a prospective observational cohort study specifically for cancer patients which will be recruited alongside the Principal ISARIC CCP-UK protocol in the UK. The study is an observatory, data collection study.

What are the possible benefits and risks of participating?
There are no direct benefits or risks to any participants; there are no interactions with the study team and unlikely participants will be aware of their data being used in this study.

Where is the study run from?
The study is managed by the Liverpool Clinical Trials Centre, under the Sponsorship of Clatterbridge Cancer Centre NHS FT (UK)

When is the study starting and how long is it expected to run for?
August 2020 to March 2022

Who is funding the study?
CCP Cancer UK is funded by the UKRI on a rapid call grant for COVID research.

Who is the main contact?
The Study coordinator will be contacted on CCPcanceruk@liverpool.ac.uk

Contact information

Dr Study Coordinator
Scientific

University of Liverpool
Department of Molecular and Clinical Cancer Medicine
Sherrington Building
Ashton Street
Liverpool
L69 3GE
United Kingdom

Email	CCPCancerUK@liverpool.ac.uk

Study information

Study design	Observational; Design type: Cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	No participant information sheet available
Scientific title	CCP-Cancer UK: Clinical Characterisation Protocol for Severe Emerging Infections in the UK (CCP-UK) – a prospective companion study for patients with cancer and COVID-19
Study acronym	CCP-Cancer UK
Study objectives	The purpose of CCP-CANCER UK study is to obtain additional data from patients with cancer who were/are recruited into the Principal CCP-UK study which is the key national protocol for characterising COVID19 in the UK population. This study is designed to supplement, not replace, the Principal CCP-UK protocol. This study will be open to research sites who are currently participating in the Principal CCP-UK study. The CCP-Cancer UK study will run for two years. An additional specific cancer data set will be collected from participant's existing medical records. This cancer specific information when combined with the rich data set related to the COVID-19 episode (derived from CCP-UK) will enable a full understanding of COVID-19 in patients with cancer as well as enable a comparison with non-cancer patients.
Ethics approval(s)	Approved 11/08/2020, East Midlands - Leicester Central REC (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, United Kingdom; +44 (0)207 104 8388; leicestercentral.rec@hra.nhs.uk), ref: 20/EM/0205
Health condition(s) or problem(s) studied	Cancer, COVID-19 (SARS-CoV-2 infection)
Intervention	This is a prospective observational cohort study collecting a cancer specific dataset from participants enrolled onto the CCP-UK study. The CCP-CANCER UK study is a companion study to the Principal CCP-UK study which involves the collection of additional data from patient case records for patients with proven COVID-19 and a diagnosis of cancer who are enrolled into any tier of the Principal CCP-UK protocol. Linkage of the CCP-Cancer UK data set with the CCP-UK data set will enable outcomes to be determined for COVID-19 patients with a diagnosis of cancer. Participants on the principal CCP-UK study who fall into the subset of COVID19 patients with a confirmed malignancy will be identified by the CCP-UK research team who will inform the CCP-Cancer UK research team. The CCP-Cancer UK team will contact cancer staff at research sites and request that the CCP-Cancer UK dataset is completed. Site staff register the participant on the study database. A specific limited CCP-Cancer UK data set will be recorded by the research team at the participating centre from existing medical records. Should this information not be retrievable by the research site a request will be made to cancer registries. Should the participant have donated samples as part of the principal CCP-UK study access to these will be requested from CCP-UK for analysis. The CCP-Cancer UK study does not require any additional patient visits, assessments or sample collections as these are all integral to the Principal CCP-UK protocol
Intervention type	Other
Primary outcome measure	Primary outcome measure as of 30/04/2024: Measured at the end of the study: 1. Determine the mortality rate in patients with cancer and COVID-19, using data from the CCP-UK study and linked data 2. Identify factors associated with the poor outcomes in patients with cancer and COVID-19, using data from the CCP-UK study and linked data Previous primary outcome measure: Measured at the end of the study: 1. Mortality rate in patients with cancer and COVID-19, using data from the CCP-UK study and linked data 2. Factors associated with the poor outcomes in patients with cancer and COVID-19, using data from the CCP-UK study and linked data
Secondary outcome measures	Secondary outcome measure as of 30/04/2024: Measured using data from the CCP-UK study and linked data throughout the study: 1. Describe the clinical features and severity of COVID-19 in different tumour types 2. Identify other clinical and laboratory variables that correlate with COVID-19 severity and mortality in different tumour types 3. Determine the influence of disease stage, treatment intent and treatment history on the severity and COVID-19 fatality rate 4. Determine the potential influence of genomic variations on the severity and outcome of COVID-19 episodes, where linked genomic data are available for example from ISARIC4C or GenoMICC 5. Describe the use of healthcare resources (including intensive care) in the treatment of COVID-19 in different tumour types. 6. Undertake a matched cohort study using cancer and non-cancer patients with COVID-19, using patients without cancer as controls from the CCP-UK dataset Exploratory outcome measures: 7. To investigate the biology of SARS-CoV-2 in the context of cancer-associated or iatrogenic immunosuppression 8. To investigate how COVID-19 interacts with cancer-related immunosuppression Previous secondary outcome measure: Measured using data from the CCP-UK study and linked data throughout the study: 1. Time to death measured as the time from COVID diagnosis to death by any cause 2. Time to recovery measured as the time from diagnosis to recovery 3. ITU admission 4. Clinical features and degree of severity of infection (Mild – no oxygen requirement, admission length <7 days; Moderate – ward level oxygen administered; Severe – ITU admission, death, NIV, high flow oxygen administered) 5. Clinical and laboratory variables that correlate with COVID-19 severity and fatality rate 6. Healthcare resource use Exploratory outcome measures: 7. Microbial diversity measured by microbial diversity index (16s rDNA) at baseline and during transition from infection to convalescence
Overall study start date	11/08/2020
Completion date	31/03/2022

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned Sample Size: 950; UK Sample Size: 950
Total final enrolment	5000
Key inclusion criteria	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	None in addition to those specified in the Principal CCP-UK protocol: Exclusion criteria specified in CCP-UK Protocol: 1. Confirmed diagnosis of a pathogen unrelated to the objectives of this study and no indication or likelihood of co-infection with a relevant pathogen 2. Refusal by participant, parent or appropriate representative
Date of first enrolment	21/03/2021
Date of final enrolment	31/03/2022

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Liverpool

Department of Molecular and Clinical Cancer Medicine
Sherrington Building
Ashton Street
Liverpool
L69 3GE
United Kingdom

Sponsor information

Clatterbridge Cancer Centre NHS Foundation Trust
Hospital/treatment centre

Clatterbridge Road
Bebington
Wirral
CH63 4JY
England
United Kingdom

Phone	+44 (0)1515565321
Email	maria.maguire2@nhs.net
Website	http://www.clatterbridgecc.nhs.uk/
"ROR"	https://ror.org/05gcq4j10

Funders

Funder type

Charity

Clatterbridge Cancer Charity

No information available

National Institute for Health Research (NIHR) (UK)
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

UK Research and Innovation
Government organisation / National government

Alternative name(s): UKRI
Location: United Kingdom

Results and Publications

Intention to publish date	31/12/2022
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Stored in repository
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal.
IPD sharing plan	The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. The pseudo anonymised data will be stored for CCP Cancer UK on the Liverpool Universtiy REDCAP Server. The anonymised dataset will be transferred to be linked with the ISARIC CCP UK data on the Data Safe Haven at the University of Edinburgh. Data is being obtained under the COPI notice for UPH COVID studies, and a later CAG application for 251 exemption for when the COPI Expires.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No
Protocol file	version 4.0	21/04/2023	13/05/2024	No	No

Additional files

ISRCTN15019599_Protocol_v4.0_21April2023.pdf

Editorial Notes

13/05/2024: Protocol (not peer reviewed uploaded).
02/05/2024: The target number of participants was changed from "Planned Sample Size: 9,000; UK Sample Size: 9,000" to "Planned Sample Size: 950; UK Sample Size: 950".
30/04/2024: The following changes were made:
1. The overall study end date was changed from 24/08/2022 to 31/03/2022.
2. The primary and secondary outcome measures were changed.
3. The total final enrolment was added.
4. The recruitment start date was changed from 04/01/2021 to 21/03/2021.
5. The recruitment end date was changed from 01/12/2021 to 31/03/2022.
17/03/2021: the NCT number has been added.
02/12/2020: The recruitment start date was changed from 01/12/2020 to 04/01/2021.
19/11/2020: Internal review.
09/11/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR).