Screening of Cancer Patients to Assess Impact of COVID-19

Sponsor

University Health Network, Toronto (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04373005

Collaborator

(none)

Enrollment

Location

25.6

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid-19 Cancer	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 Design

Study Type:

Observational

Actual Enrollment :

83 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 11, 2020

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Rate of asymptomatic COVID-19 infection among cancer patients receiving cancer therapy [12 months]

Secondary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Asymptomatic for COVID-19 (as per daily screening at the hospital entrance).
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Princess Margaret Cancer Centre	Toronto	Ontario	Canada	M5G 1Z5

Sponsors and Collaborators

University Health Network, Toronto

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT04373005

Other Study ID Numbers:

U-DEPLOY: RESPONSE
CAPCR 20-5337

First Posted:

May 4, 2020

Last Update Posted:

May 11, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of May 11, 2022