Condition category
Cancer
Date applied
06/10/2020
Date assigned
10/11/2020
Last edited
19/11/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

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. As of March 2020, it is 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 August 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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Study Coordinator

ORCID ID

Contact details

University of Liverpool
Department of Molecular and Clinical Cancer Medicine
Sherrington Building
Ashton Street
Liverpool
L69 3GE
United Kingdom
-
CCPCancerUK@liverpool.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 46602, IRAS 285044

Study information

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

Acronym

CCP-Cancer UK

Study hypothesis

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

Approved 11/08/2020, East Midlands - Leicester Central REC (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)207 104 8388; leicestercentral.rec@hra.nhs.uk), ref: 20/EM/0205

Study design

Observational; Design type: Cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

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

Phase

Drug names

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

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 trial start date

11/08/2020

Overall trial end date

24/08/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 9,000; UK Sample Size: 9,000

Participant 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

Recruitment start date

01/12/2020

Recruitment end date

01/12/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Clatterbridge Cancer Centre NHS Foundation Trust

Sponsor details

Clatterbridge Road
Bebington
Wirral
CH63 4JY
United Kingdom
+44 (0)1515565321
maria.maguire2@nhs.net

Sponsor type

Hospital/treatment centre

Website

http://www.clatterbridgecc.nhs.uk/

Funders

Funder type

Charity

Funder name

Clatterbridge Cancer Charity

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Institute for Health Research (NIHR) (UK)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Funder name

UK Research and Innovation

Alternative name(s)

UKRI

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
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.

Intention to publish date

31/12/2022

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

19/11/2020: Internal review. 09/11/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR).