Screening of Cancer Patients to Assess Impact of COVID-19

A Research Platform to Screen Patients in Oncology and Assess Impact - RESPONSE

The purpose of this study is to investigate the impact of COVID -19 in the cancer patient population. This will be done by looking at the rate of asymptomatic COVID-19 infection in cancer patients receiving cancer therapy, as well as their immune response.

This is a sub-study of the U-DEPLOY study: UHN Umbrella Trial Defining Coordinated Approach to Pandemic Trials of COVID-19 and Data Harmonization to Accelerate Discovery. U-DEPLOY helps to facilitate timely conduct of studies across the University Health Network (UHN) and other centers.

Study Overview

• Status: Terminated
• Conditions: Covid-19; Cancer
• Intervention / Treatment: Diagnostic test: Nasopharyngeal (NP) swab

Detailed Description

Given increasing community transmission and the possibility of asymptomatic carriage of virus, it is important to study whether asymptomatic shedders of virus are playing a role in propagating the pandemic. There is currently little data available regarding cancer patients, yet, this population may be particularly susceptible to the COVID-19 infection.

Despite the cancer patient population being at higher risk of COVID-19, no systematic screening has been established and no biomarkers have been identified to determine which patient is at higher risk.

This study will screen patients on active cancer therapy for COVID-19 as a standard of care or a research nasopharyngeal test. Blood samples may also be taken to assess any patient response to the virus and optional saliva samples may also be taken to assess the feasibility of using patient saliva for detection of SARS-CoV-2 virus in patients with impaired saliva production (eg. secondary to cancer treatments such as radiation, chemotherapy, and/or surgery).

• Study Type: Observational
• Enrollment (Actual): 83

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1Z5
      • Princess Margaret Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients having an active malignancy who are planned to start therapy or receiving a treatment for active malignancy involved at the University Health Network and any other centres that choose to participate that are asymptomatic to COVID-19 for in-patients or ambulatory patients.

Description

Inclusion Criteria:

• Patients having an active malignancy who are planned to start therapy within 6 weeks of consent or are receiving a treatment for active malignancy.

• The patient falls under either of the following categories:

  1. Asymptomatic for COVID-19 (as per daily screening at the hospital entrance).
  2. Has symptoms similar to those of COVID-19 (e.g. fever or flu-like symptoms such as cough or shortness of breath) that are assessed by the overseeing Investigator as being related to disease and unrelated to COVID-19 infection.

Note: Patients who recovered from previous COVID-19 infection will be eligible.

• No contraindication to performing a NP swab and blood work.

Exclusion Criteria:

• Any patients with fever, or flu-like symptoms assessed by the Investigator to be related or potentially related to COVID-19 infection will not be eligible.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 3-4

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Nasopharyngeal (NP) swabs; NP swabs: At the time of consent; 3-6 weeks after starting cancer treatment (for patients whose treatment has yet not started) or 3-6 weeks after first swab (for patients already on treatment); 3 months after second swab; 6 months after second swab; 12 months after second swab	Diagnostic test: Nasopharyngeal (NP) swab; A dry swab will be inserted through one nostril straight towards the back of the nasal passage and rotated gently before the swab is removed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of asymptomatic COVID-19 infection among cancer patients receiving cancer therapy	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of sero-conversion in cancer patients	12 months
Describe the clinical course of COVID-19 infection in cancer patients	12 months

Other Outcome Measures

Outcome Measure	Time Frame
Feasibility of using patient saliva for detection of SARS-CoV-2 virus in patients with impaired saliva production	12 months
Compare the evolution of immune and proteomic profile of asymptomatic COVID-19 negative and positive cancer patients	12 months

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Stephanie Lheureux, M.D., Princess Margaret Cancer Centre

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2020
• Primary Completion (Actual): October 6, 2022
• Study Completion (Actual): October 6, 2022

Study Registration Dates

• First Submitted: April 30, 2020
• First Submitted That Met QC Criteria: April 30, 2020
• First Posted (Actual): May 4, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: U-DEPLOY: RESPONSE; CAPCR 20-5337 (Other Identifier: University Health Network)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No