Study Stopped
Participants were not testing positive for COVID-19 and were not returning onsite for visits.
Screening of Cancer Patients to Assess Impact of COVID-19
A Research Platform to Screen Patients in Oncology and Assess Impact - RESPONSE
2 other identifiers
observational
83
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2020
CompletedFirst Posted
Study publicly available on registry
May 4, 2020
CompletedStudy Start
First participant enrolled
May 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 6, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 6, 2022
CompletedDecember 3, 2025
November 1, 2025
2.4 years
April 30, 2020
November 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of asymptomatic COVID-19 infection among cancer patients receiving cancer therapy
12 months
Secondary Outcomes (2)
Rate of sero-conversion in cancer patients
12 months
Describe the clinical course of COVID-19 infection in cancer patients
12 months
Other Outcomes (2)
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
Study Arms (1)
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
Interventions
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
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.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 1Z5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephanie Lheureux, M.D.
Princess Margaret Cancer Centre
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2020
First Posted
May 4, 2020
Study Start
May 11, 2020
Primary Completion
October 6, 2022
Study Completion
October 6, 2022
Last Updated
December 3, 2025
Record last verified: 2025-11