Covid-19NCT04373005
Screening of Cancer Patients to Assess Impact of COVID-19
An observational study of Covid-19 and Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Nasopharyngeal (NP) swab
- How many people
- 83 participants
- Where
- 1 siteCanada
- Study dates
- 11 May 2020to 6 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Being tested
- Nasopharyngeal (NP) swab
- Medical subject headings
- COVID-19, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasopharyngeal (NP) swabDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Nasopharyngeal (NP) swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of asymptomatic COVID-19 infection among cancer patients receiving cancer therapy
Measured: 12 months
Secondary outcomes (2)
Rate of sero-conversion in cancer patients
Measured: 12 months
Describe the clinical course of COVID-19 infection in cancer patients
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start11 May 2020
- Primary completion6 Oct 2022
- Study completion6 Oct 2022
Why it stopped: Participants were not testing positive for COVID-19 and were not returning onsite for visits.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Lheureux, M.D., Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373005
- Sponsor's protocol ID
- U-DEPLOY: RESPONSE
- Other IDs
- CAPCR 20-5337
- Status last verified
- Nov 2025
- First submitted
- 30 Apr 2020
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Research Platform to Screen Patients in Oncology and Assess Impact - RESPONSE
- ClinicalTrials.gov ID
- NCT04373005
- Acronym / sponsor ID
- U-DEPLOY: RESPONSE
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Participants were not testing positive for COVID-19 and were not returning onsite for visits.
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 11 May 2020 (actual)
- Primary completion
- 6 Oct 2022 (actual)
- Study completion
- 6 Oct 2022 (actual)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasopharyngeal (NP) swabs | – | Diagnostic Test: Nasopharyngeal (NP) swabNP 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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:
- Note: Patients who recovered from previous COVID-19 infection will be eligible.
- No contraindication to performing a NP swab and blood work.
Key exclusion criteria (2 listed)
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasopharyngeal (NP) swabA dry swab will be inserted through one nostril straight towards the back of the nasal passage and rotated gently before the swab is removed. | Diagnostic test | Nasopharyngeal (NP) swabs |
Primary outcome
Rate of asymptomatic COVID-19 infection among cancer patients receiving cancer therapy
Time frame: 12 months
2 secondary outcomes
Rate of sero-conversion in cancer patients
Time frame: 12 months
Describe the clinical course of COVID-19 infection in cancer patients
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Participants were not testing positive for COVID-19 and were not returning onsite for visits.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Lheureux, M.D. principal investigator
Princess Margaret Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19 and Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Participants were not testing positive for COVID-19 and were not returning onsite for visits.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of asymptomatic COVID-19 infection among cancer patients receiving cancer therapy (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.