Clinical trial NCT04373005: Screening of Cancer Patients to Assess Impact of COVID-19
Official title: A Research Platform to Screen Patients in Oncology and Assess Impact - RESPONSE
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Covid-19
Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2020-05-04
Enrollment: 83
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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

Primary outcomes:
measure: Rate of asymptomatic COVID-19 infection among cancer patients receiving cancer therapy
timeFrame: 12 months
Secondary outcomes:
measure: Rate of sero-conversion in cancer patients
timeFrame: 12 months
measure: Describe the clinical course of COVID-19 infection in cancer patients
timeFrame: 12 months
Other outcomes:
measure: Feasibility of using patient saliva for detection of SARS-CoV-2 virus in patients with impaired saliva production
timeFrame: 12 months
measure: Compare the evolution of immune and proteomic profile of asymptomatic COVID-19 negative and positive cancer patients
timeFrame: 12 months
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: Princess Margaret Cancer Centre
name: Stephanie Lheureux, M.D.
role: PRINCIPAL_INVESTIGATOR
References: