Official Title
A Research Platform to Screen Patients in Oncology and Assess Impact - RESPONSE
Brief Summary

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.

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).

Active, not recruiting
COVID-19
Cancer

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.

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: N/A ~ Maximum: N/A
Countries
Canada
Locations

Princess Margaret Cancer Centre
Toronto, Ontario, Canada

Stephanie Lheureux, M.D., Principal Investigator
Princess Margaret Cancer Centre

University Health Network, Toronto
NCT Number
MeSH Terms
COVID-19