CCP Cancer UK Companion Study

NCT04603105 | Active Not Recruiting

• 1 other identifier: C1147
• Study Type: observational
• Target: 9,000
• Locations: 1 country
• Sites: 1

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

Conditions

Cancer; Covid19

Outcome Measures

Primary Outcomes (2)

• 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

  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

  12 months

Secondary Outcomes (5)

• To describe the clinical features and severity of COVID-19 in different tumour types.

  12 months

• To identify other clinical and laboratory variables that correlate with COVID-19 severity and mortality in different tumour types.

  12 months

• To determine the influence of disease stage, treatment intent and treatment history on severity and COVID-19 fatality rate.

  12 months

• To describe the use of healthcare resources (including intensive care) in the treatment of COVID-19 in different tumour types.

  12 months

• To undertake a matched cohort study using the cancer and non-cancer patients with COVID-19.

  12 months

Study Arms (1)

Single Study Cohort

Patients will be recruited from the main study after being determined to having COVID-19 and Cancer

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Clatterbridge Cancer Centre NHS Foundation Trust: lead
• University of Edinburgh: collaborator
• University of Oxford: collaborator
• University of Liverpool: collaborator

Study Sites (1)

The Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool, L78YA, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms; COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

• Carlo Palmieri

  Clatterbridge Cancer Centre NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Lance Turtle

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 26, 2020
• Study Start: February 28, 2021
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2025
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)